510(k) Report

510(k) · Cleared

Cleared

Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System

K110626510(k) SpecialCleared Apr 20, 201147-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

Pathway Medical Technologies, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on Apr 20, 2011 as substantially equivalent to K101221 (Pathway Medical Technologies, Inc., 2010) and 6 other predicates after a 47-day review. Its family tree reaches back 16 generations to 1987. 3 of the 50 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided
Apr 20, 2011
Review
47 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
7

Its longest line of descent runs back 16 generations to K871011 (1987). 39 ancestors in all, the oldest K780551 (1978). 10 later devices descend from it, 3 citing it directly. 3 of the 50 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 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 ancestor2013: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2018: 2 descendants cleared, 1 with a Class I recall12014: 1 descendant cleared2021: 2 descendants 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), K101221 (2010) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 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: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants, 1 with a Class I recall14 generations forward: 1 descendant, 1 with a Class I recall15 generations forward: 1 descendant, 1 with a Class I recall1 K101221 · Jetstream G3 System, Model PV31300, PV Console, Model PVCN100 · 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+5
  1. Root · 16 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 12 generations between
  3. 3 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
  4. 2 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
  5. 1 generation backK101221 Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010
  6. This deviceK110626 Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE…Pathway Medical Technologies, Inc. · 2011
  7. Descendant · cites it directly · 6 of its ownK122916 Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF…Medrad, Inc. · 2012
  8. Descendant · cites it directly · 5 of its ownK130637 Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream…Medrad, Inc. · 2013
  9. Descendant · 2 generations on · 3 of its ownK133023 Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85…Medrad, Inc. · 2014 · Recalled
  10. Descendant · 3 generations on · 2 of its ownK172315 Straub Endovascular SystemStraub Medical AG · 2018 · Recalled (Class I)
  11. Descendant · cites it directly · 2 of its ownK112308 Crosser Recanalization SystemC.R. Bard, Inc. · 2011
Show all 16 generations
  1. Root · 16 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 15 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
  3. 14 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
  4. 13 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
  5. 12 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
  6. 11 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  7. 10 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  8. 9 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
  9. 8 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  10. 7 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  11. 6 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
  12. 5 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
  13. 4 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
  14. 3 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
  15. 2 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
  16. 1 generation backK101221 Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010
  17. This deviceK110626 Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE…Pathway Medical Technologies, Inc. · 2011

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12013: 12014: 12016: 12018: 22021: 22025: 1
2011high 2 (2018) · low 0 (2015)2026

Class I recalls in this family

  • K172315 Straub Endovascular System3 generations on · 2018
  • K211738 Rotarex Atherectomy System4 generations on · 2021
  • K242757 Rotarex Atherectomy System5 generations on · 2025

Most influential descendants

Showing 5 of 10 · See all
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc. · 2012 · cites it directly6descendants
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc. · 2013 · cites it directly5descendants
  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 2014 · 2 generations on3descendants
  • K172315Straub Endovascular SystemStraub Medical AG · 2018 · 3 generations on2descendants
  • K112308Crosser Recanalization SystemC.R. Bard, Inc. · 2011 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K871011Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc.1987—
−15K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies20031
−14K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200…Fox Hollow Technologies2005—
−13K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550…Fox Hollow Technologies2006—
−12K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models…Foxhollow Technologies, Inc.2006—
−11K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−10K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−9K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc.2008—
−8K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−7K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−6K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.2009—
−5K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).…Pathway Medical Technologies, Inc.2009—
−4K093456Jetstream G3 SystemPathway Medical Technologies, Inc.2009—
−3K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control…Pathway Medical Technologies, Inc.2010—
−2K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.2010—
−1K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc.2010—
0 (this device)K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System…Pathway Medical Technologies, Inc.2011—
+1K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System…Medrad, Inc.2012—
+1K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85…Medrad, Inc.2013—
+2K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.20141
+3K172315Straub Endovascular SystemStraub Medical AG2018Class I
+1K112308Crosser Recanalization SystemC.R. Bard, Inc.2011—

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201310
201410
201610
201821
202121
202511
FIG. 1 — Lineage of K110626, 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? (7)

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
*K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100
Summary page 3
…-- ,Pathi ay Medical Pridicae 510(k) JETSTREAM G38 System K101221 JETSTREAM G38 SF System K 101334 JETSTRFAM G30 SE System…
Pathway Medical Technologies, Inc.2010—
*K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…
Summary page 3
…Pridicae 510(k) JETSTREAM G38 System K101221 JETSTREAM G38 SF System K 101334 JETSTRFAM G30 SE System K101334 .IE-TSTREAM G38 L System…
Pathway Medical Technologies, Inc.2010—
*K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100
Summary page 3
…K 101334 JETSTRFAM G30 SE System K101334 .IE-TSTREAM G38 L System K100462 IETSTREAM G39® L System K093918 JETSTREAM G2Tm NXT System…
Pathway Medical Technologies, Inc.2010—
*K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…
Summary page 3
…K101334 .IE-TSTREAM G38 L System K100462 IETSTREAM G39® L System K093918 JETSTREAM G2Tm NXT System K091509 JTETSTREAM Pathway PVTM Atherectomy System…
Pathway Medical Technologies, Inc.2010—
*K091509Jetstream G2 NXT System, Model PV20300
Summary page 3
…K100462 IETSTREAM G39® L System K093918 JETSTREAM G2Tm NXT System K091509 JTETSTREAM Pathway PVTM Atherectomy System K(082 186 PaharPT terectomy System…
Pathway Medical Technologies, Inc.2009—
*K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
*K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—

Also cleared against K101221: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc.20126
K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc.20135
K112308Crosser Recanalization SystemC.R. Bard, Inc.20112

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 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
  • K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3 months on median.
  • 6 of the 39 ancestors have a recall of any class.
  • Of its descendants, K122916 (Medrad, Inc., 2012) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K101221.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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.

Also cleared against K101221

2 other devices cite the same predicate.

  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012

More from Pathway Medical Technologies, Inc.

16 FDA decisions under this applicant name. See the company

  • K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
  • K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
  • K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter and Control Pod)…Pathway Medical Technologies, Inc. · 2010
  • K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010
  • K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010

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/K110626 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110626: Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110626

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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