510(k) Report

510(k) · Cleared

Cleared

Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100

K082664510(k) SpecialCleared Oct 6, 200824-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 Oct 6, 2008 as substantially equivalent to K081328 (Pathway Medical Technologies, Inc., 2008) and 1 other predicate after a 24-day review. Its family tree reaches back 7 generations to 1987. 3 of the 50 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it.

Decided
Oct 6, 2008
Review
24 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
2

Its longest line of descent runs back 7 generations to K871011 (1987). 17 ancestors in all. 32 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 2006: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1988: 3 other ancestors2009: 6 descendants cleared2019: 1 descendant cleared2010: 4 descendants cleared2021: 4 descendants cleared, 1 with a Class I recall12013: 1 descendant cleared2012: 2 descendants cleared2011: 3 descendants cleared2014: 4 descendants cleared2018: 3 descendants cleared, 1 with a Class I recall12016: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2025: 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) ×2: 2 generations cleared close together, K081328 (2008), K082186 (2008) 1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 7 other ancestors3 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 6 descendants4 generations forward: 6 descendants5 generations forward: 4 descendants, 1 with a Class I recall16 generations forward: 5 descendants, 1 with a Class I recall17 generations forward: 2 descendants, 1 with a Class I recall1 K082186 · 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. · 1987−50+5
  1. Root · 7 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 6 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
  3. 5 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
  4. 4 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
  5. 3 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
  6. 2 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  7. 1 generation backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  8. This deviceK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
  9. Descendant · cites it directly · 28 of its ownK083489 Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009
  10. Descendant · cites it directly · 28 of its ownK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  11. Descendant · 2 generations on · 27 of its ownK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  12. Descendant · 2 generations on · 26 of its ownK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
  13. Descendant · 2 generations on · 25 of its ownK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2009: 62010: 42011: 32012: 22013: 12014: 42015: 12016: 12017: 12018: 32019: 12021: 42025: 1
2009high 6 (2009) · low 0 (2020)2026

Class I recalls in this family

  • K172315 Straub Endovascular System5 generations on · 2018
  • K211738 Rotarex Atherectomy System6 generations on · 2021
  • K242757 Rotarex Atherectomy System7 generations on · 2025

Most influential descendants

Showing 5 of 32 · See all
  • K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009 · cites it directly28descendants
  • K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc. · 2009 · cites it directly28descendants
  • K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc. · 2009 · 2 generations on27descendants
  • K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009 · 2 generations on26descendants
  • K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…Pathway Medical Technologies, Inc. · 2009 · 2 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K871011Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc.1987—
−6K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies20031
−5K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200…Fox Hollow Technologies2005—
−4K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550…Fox Hollow Technologies2006—
−3K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models…Foxhollow Technologies, Inc.2006—
−2K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−1K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
0 (this device)K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc.2008—
+1K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc.2009—
+1K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
+2K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
+2K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.2009—
+2K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).…Pathway Medical Technologies, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198830
198910
199010
199310
199610
199710
199910
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200960
201040
201130
201220
201310
201440
201510
201610
201710
201831
201910
202141
202511
FIG. 1 — Lineage of K082664, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (2)

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
*K081328Pathway PV Atherectomy System
Summary page 1
…Class 11 Classification Panel: Cardiovascular Product Code: MCW Predicate Device: 510(k) Number: K081328, K082186 Manufacturer: Pathway Medical Technologies, Inc.…
Pathway Medical Technologies, Inc.2008—
*K082186Modification to Pathway PV Atherectomy System
Summary page 1
…11 Classification Panel: Cardiovascular Product Code: MCW Predicate Device: 510(k) Number: K081328, K082186 Manufacturer: Pathway Medical Technologies, Inc.…
Pathway Medical Technologies, Inc.2008—

Also cleared against K081328: 14 other devices →

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc.200928
K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc.200928
K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireRex Medical, L.P.20191

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 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
  • K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 11 months on median.
  • 2 of the 17 ancestors have a recall of any class.
  • Of its descendants, K083489 (Pathway Medical Technologies, Inc., 2009) has gone furthest, with 28 descendants of its own.
  • 14 other devices also cite its predicate K081328.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Pathway PV Atherectomy System is intended for use in atherectomy of the peripheral vasculature. 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 K081328

14 other devices cite the same predicate.

  • K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting…Atheromed, Inc. · 2014
  • 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
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
  • K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
  • K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L SystemPathway Medical Technologies, Inc. · 2011

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
  • K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L 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

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/K082664 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082664: Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082664

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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