510(k) Report

510(k) · Cleared

Cleared

Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 System

K130637510(k) SpecialCleared Apr 10, 201330-day reviewClass II21 CFR 870.4875

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medrad, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on Apr 10, 2013 as substantially equivalent to K122916 (Medrad, Inc., 2012) and 10 other predicates after a 30-day review. Its family tree reaches back 19 generations to 1987. 3 of the 49 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.

Decided
Apr 10, 2013
Review
30 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
11

Its longest line of descent runs back 19 generations to K871011 (1987). 43 ancestors in all, the oldest K780551 (1978). 5 later devices descend from it, 2 citing it directly. 3 of the 49 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2009: 1 other ancestor2006: 2 other ancestors1999: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1993: 1 other ancestor1990: 2 other ancestors1989: 1 other ancestor2007: 1 other ancestor1988: 3 other ancestors2005: 1 other ancestor2004: 1 other ancestor2000: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1978: 1 other ancestor2018: 2 descendants cleared, 1 with a Class I recall12014: 1 descendant cleared2021: 1 descendant cleared, 1 with a Class I recall12025: 1 descendant cleared, 1 with a Class I recall1K871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005×2: 2 generations cleared close together, K053460 (2006), K061063 (2006) ×11: 11 generations cleared close together, K081328 (2008), K082186 (2008), K082664 (2008), K083837 (2009), K090325 (2009), K091509 (2009), K092332 (2009), K093456 (2009), K093918 (2010), K100462 (2010), K101334 (2010) K111229 · Jetstream G3 (R) SF 1.6 System · Pathway Medical Technologies, Inc. · 2011K120242 · Jetstream Navitus L System · Pathway Medical Technologies, Inc. · 2012K122916 · Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 System · Medrad, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors3 generations back: 4 other ancestors4 generations back: 3 other ancestors5 generations back: 5 other ancestors6 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant, 1 with a Class I recall13 generations forward: 1 descendant, 1 with a Class I recall14 generations forward: 1 descendant, 1 with a Class I recall1 K122916 · Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 System · Medrad, Inc. · 2012K120242 · Jetstream Navitus L System · Pathway Medical Technologies, Inc. · 2012K111229 · Jetstream G3 (R) SF 1.6 System · Pathway Medical Technologies, Inc. · 2011K101334 · Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter and Control Pod); PVCN100 (PV Con · Pathway Medical Technologies, Inc. · 2010K100462 · Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 · Pathway Medical Technologies, Inc. · 2010K093918 · Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2010K093456 · Jetstream G3 System · Pathway Medical Technologies, Inc. · 2009K092332 · Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K091509 · Jetstream G2 NXT System, Model PV20300 · Pathway Medical Technologies, Inc. · 2009K090325 · Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K083837 · Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K082664 · Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 · Pathway Medical Technologies, Inc. · 2008K082186 · Modification to Pathway PV Atherectomy System · Pathway Medical Technologies, Inc. · 2008K081328 · Pathway PV Atherectomy System · Pathway Medical Technologies, Inc. · 2008K061063 · Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300 · Foxhollow Technologies, Inc. · 2006K053460 · Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300, · Fox Hollow Technologies · 2006K043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987−15−10−50
  1. Root · 19 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 15 generations between
  3. 3 generations backK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
  4. 2 generations backK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
  5. 1 generation backK122916 Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF…Medrad, Inc. · 2012
  6. This deviceK130637 Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream…Medrad, Inc. · 2013
  7. Descendant · cites it directly · 3 of its ownK133023 Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85…Medrad, Inc. · 2014 · Recalled
  8. Descendant · 2 generations on · 2 of its ownK172315 Straub Endovascular SystemStraub Medical AG · 2018 · Recalled (Class I)
  9. Descendant · 3 generations on · 1 of its ownK211738 Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · Recalled (Class I)
  10. Descendant · 4 generations on · 0 of its ownK242757 Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · Recalled (Class I)
  11. Descendant · cites it directly · 0 of its ownK181877 Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc. · 2018
Show all 19 generations
  1. Root · 19 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 18 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
  3. 17 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
  4. 16 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
  5. 15 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
  6. 14 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  7. 13 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  8. 12 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
  9. 11 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  10. 10 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  11. 9 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
  12. 8 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
  13. 7 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
  14. 6 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
  15. 5 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
  16. 4 generations backK101334 Jetstream G3 SE System, Jetstream G3 SF System Model PV31230…Pathway Medical Technologies, Inc. · 2010
  17. 3 generations backK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
  18. 2 generations backK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
  19. 1 generation backK122916 Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF…Medrad, Inc. · 2012
  20. This deviceK130637 Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream…Medrad, Inc. · 2013

Class I recalls in this family

  • K172315 Straub Endovascular System2 generations on · 2018
  • K211738 Rotarex Atherectomy System3 generations on · 2021
  • K242757 Rotarex Atherectomy System4 generations on · 2025

Most influential descendants

Showing 5 of 5 · See all
  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 2014 · cites it directly3descendants
  • K172315Straub Endovascular SystemStraub Medical AG · 2018 · 2 generations on2descendants
  • K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 3 generations on1descendant
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 4 generations on0descendants
  • K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K871011Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc.1987—
−18K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies20031
−17K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200…Fox Hollow Technologies2005—
−16K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550…Fox Hollow Technologies2006—
−15K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models…Foxhollow Technologies, Inc.2006—
−14K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−13K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−12K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc.2008—
−11K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−10K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−9K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.2009—
−8K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).…Pathway Medical Technologies, Inc.2009—
−7K093456Jetstream G3 SystemPathway Medical Technologies, Inc.2009—
−6K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control…Pathway Medical Technologies, Inc.2010—
−5K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.2010—
−4K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE…Pathway Medical Technologies, Inc.2010—
−3K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc.2011—
−2K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.2012—
−1K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System…Medrad, Inc.2012—
0 (this device)K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85…Medrad, Inc.2013—
+1K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.20141
+2K172315Straub Endovascular SystemStraub Medical AG2018Class I
+3K211738Rotarex Atherectomy SystemC.R. Bard, Inc.2021Class I
+4K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.2025Class I
+1K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198830
198910
199020
199110
199310
199510
199620
199710
199910
200020
200410
200510
200620
200710
200910
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201821
202111
202511
FIG. 1 — Lineage of K130637, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MCW device

  1. #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…
Summary page 7
…Predicate 510(k) JETSTREAM Navitus® L System JETSTREAM Navitus® System K122916 JETSTREAM G3® SF System JETSTREAM G3® SF 1.6 System However, the design rationale for and device testing of th…
Medrad, Inc.2012—
*K120242Jetstream Navitus L System
Summary page 7
…Pathway Medical Predicate 510(k) JETSTREAM Navitus® L System K120242 JETSTREAM G3® SF 1.6 System K111229 JETSTREAM Navitus® System…
Pathway Medical Technologies, Inc.2012—
*K111229Jetstream G3 (R) SF 1.6 System
Summary page 7
…Predicate 510(k) JETSTREAM Navitus® L System K120242 JETSTREAM G3® SF 1.6 System K111229 JETSTREAM Navitus® System K110626 JETSTREAM G3® SF System…
Pathway Medical Technologies, Inc.2011—
*K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…
Summary page 7
…K120242 JETSTREAM G3® SF 1.6 System K111229 JETSTREAM Navitus® System K110626 JETSTREAM G3® SF System K101334 JETSTREAM G3® System…
Pathway Medical Technologies, Inc.2011—
*K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…
Summary page 7
…K111229 JETSTREAM Navitus® System K110626 JETSTREAM G3® SF System K101334 JETSTREAM G3® System K101221 JETSTREAM G3® System…
Pathway Medical Technologies, Inc.2010—
*K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100
Summary page 7
…K110626 JETSTREAM G3® SF System K101334 JETSTREAM G3® System K101221 JETSTREAM G3® System K093456 JETSTREAM G3® System…
Pathway Medical Technologies, Inc.2010—
*K093456Jetstream G3 System
Summary page 7
…K101334 JETSTREAM G3® System K101221 JETSTREAM G3® System K093456 JETSTREAM G3® System K092332 JETSTREAM G2™ NXT System…
Pathway Medical Technologies, Inc.2009—
*K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…
Summary page 7
…K101221 JETSTREAM G3® System K093456 JETSTREAM G3® System K092332 JETSTREAM G2™ NXT System K091509 JETSTREAM Pathway PV™ Atherectomy System…
Pathway Medical Technologies, Inc.2009—
*K091509Jetstream G2 NXT System, Model PV20300
Summary page 7
…K093456 JETSTREAM G3® System K092332 JETSTREAM G2™ NXT System K091509 JETSTREAM Pathway PV™ Atherectomy System K082186 Pathway PV™ Atherectomy System…
Pathway Medical Technologies, Inc.2009—
*K082186Modification to Pathway PV Atherectomy System
Summary page 7
…K092332 JETSTREAM G2™ NXT System K091509 JETSTREAM Pathway PV™ Atherectomy System K082186 Pathway PV™ Atherectomy System K081328 Testing Summary: To demonstrate substantial equivalence…
Pathway Medical Technologies, Inc.2008—
*K081328Pathway PV Atherectomy System
Summary page 7
…K091509 JETSTREAM Pathway PV™ Atherectomy System K082186 Pathway PV™ Atherectomy System K081328 Testing Summary: To demonstrate substantial equivalence of the modified Jetstream Systems to the predicate Jetstream Systems, th…
Pathway Medical Technologies, Inc.2008—

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.20143
K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K172315Straub Endovascular SystemStraub Medical AG · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
  • K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 4 months on median.
  • 6 of the 43 ancestors have a recall of any class.
  • Of its descendants, K133023 (Medrad, Inc., 2014) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · MCW

3in 2025

2007: 52008: 62009: 82010: 62011: 62012: 52013: 52014: 72015: 62016: 52017: 72018: 82019: 32020: 22021: 62022: 62023: 42024: 32025: 32026 (partial year): 1
2007high 8 (2009) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCW

46in 2025

2007: 43 days median2008: 33 days median2009: 27 days median2010: 30 days median2011: 39 days median2012: 29 days median2013: 30 days median2014: 117 days median2015: 30 days median2016: 60 days median2017: 91 days median2018: 103 days median2019: 112 days median2021: 119 days median2022: 69 days median2023: 104 days median2024: 41 days median2025: 46 days median
2007high 119 (2021) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MCW

2in 2024

2007: 22008: 12009: 32010: 12016: 22017: 22021: 2, 2 Class I2022: 2, 2 Class I2023: 12024: 2
2007high 3 (2009) · low 0 (2011)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MCW

677in 2025

2007: 502008: 1152009: 1052010: 1672011: 2042012: 1942013: 1342014: 2102015: 3772016: 4092017: 4152018: 5372019: 6182020: 6312021: 7342022: 5662023: 5742024: 6772025: 677
2007high 734 (2021) · low 50 (2007)2025

MAUDE reports naming product code MCW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007543250
20086331115
20098273105
20106301167
20116390204
20125290194
20135300134
201471170210
20156300377
20165602409
20177912415
201881030537
201931120618
20202—0631
202161192 (2)734
20226692 (2)566
202341041574
20243412677
20253460677
20261—0—

What is it indicated for?

The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Indications for use as stated in the FDA summary.

More from Medrad, Inc.

105 FDA decisions under this applicant name. See the company

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall
  • K113133Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion Arterion SyringeMedrad, Inc. · 2011

Recent decisions in MCW

The MCW category page

  • K260244Auryon Atherectomy SystemEximo Medical · 2026
  • K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc., · 2025
  • K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics · 2025
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 20251 Class I recall
  • K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc., · 2024

https://510kreport.com/device/K130637 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130637: Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130637

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026