510(k) Report

510(k) · Cleared

Cleared

Turbohawk Peripheral Plaque Excision System

K093301510(k) TraditionalCleared Nov 6, 200916-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

Ev3, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on Nov 6, 2009 as substantially equivalent to K061188 (Foxhollow Technologies, Inc., 2006) after a 16-day review. Its family tree reaches back 5 generations to 1987. 2 of the 15 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.

Decided
Nov 6, 2009
Review
16 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K871011 (1987). 8 ancestors in all. 6 later devices descend from it, 2 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1988: 3 other ancestors2011: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2016: 1 descendant cleared, 1 with a Class I recall12021: 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 · 2005K053460 · Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300, · Fox Hollow Technologies · 2006K061188 · Silverhawk Peripheral Plaque Excision System · Foxhollow Technologies, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 5 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants, 2 with a Class I recall2 K061188 · Silverhawk Peripheral Plaque Excision System · Foxhollow Technologies, Inc. · 2006 · recalledK053460 · 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
  1. Root · 5 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 4 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
  3. 3 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
  4. 2 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
  5. 1 generation backK061188 Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · Recalled
  6. This deviceK093301 Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 2009
  7. Descendant · cites it directly · 4 of its ownK111723 Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 2011 · Recalled
  8. Descendant · cites it directly · 4 of its ownK103618 Turbohawk Peropheral Plaque Excision SystemEv3, Inc. · 2011
  9. Descendant · 2 generations on · 1 of its ownK170191 SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral…Medtronic Vascular, Inc. · 2017
  10. Descendant · 2 generations on · 1 of its ownK141801 Hawkone Directional Atherectomy SystemCovidien, LLC · 2014
  11. Descendant · 3 generations on · 0 of its ownK212027 TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. · 2021 · Recalled (Class I)

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 22014: 12016: 12017: 12021: 1
2011high 2 (2011) · low 0 (2012)2026

Class I recalls in this family

  • K161361 HawkOne Directional Atherectomy System3 generations on · 2016
  • K212027 TurboHawk Plus Directional Atherectomy System3 generations on · 2021

Most influential descendants

Showing 5 of 6 · See all
  • K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 2011 · cites it directly4descendants
  • K103618Turbohawk Peropheral Plaque Excision SystemEv3, Inc. · 2011 · cites it directly4descendants
  • K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMedtronic Vascular, Inc. · 2017 · 2 generations on1descendant
  • K141801Hawkone Directional Atherectomy SystemCovidien, LLC · 2014 · 2 generations on1descendant
  • K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K871011Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc.1987—
−4K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies20031
−3K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200…Fox Hollow Technologies2005—
−2K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550…Fox Hollow Technologies2006—
−1K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc.20061
0 (this device)K093301Turbohawk Peripheral Plaque Excision SystemEv3, Inc.2009—
+1K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc.20111
+1K103618Turbohawk Peropheral Plaque Excision SystemEv3, Inc.2011—
+2K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque…Medtronic Vascular, Inc.2017—
+2K141801Hawkone Directional Atherectomy SystemCovidien, LLC2014—
+3K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.2021Class I

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198830

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201410
201611
201710
202111
FIG. 1 — Lineage of K093301, 1987–2021Source: 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.

2 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? (1)

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
*K061188Silverhawk Peripheral Plaque Excision System
Summary page 1
…oduct Code MCW Classification Panel Cardiovascular Predicate Devices SilverHawkTM Peripheral Plaque Excision System (K061188) Intended use Treatment of de novo and restenotic atherosclerotic calcified and non-…
Foxhollow Technologies, Inc.20061

Also cleared against K061188: 6 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc.20114
K103618Turbohawk Peropheral Plaque Excision SystemEv3, Inc.20114

Has anything in its family been recalled? (2 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.

  • K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
  • K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K111723 (Ev3, Inc., 2011) has gone furthest, with 4 descendants of its own.
  • 6 other devices also cite its predicate K061188.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K061188

6 other devices cite the same predicate.

  • K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMedtronic Vascular, Inc. · 2017
  • K152275Pantheris SystemAvinger, Inc. · 2015
  • K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting…Atheromed, Inc. · 2014
  • K103618Turbohawk Peropheral Plaque Excision SystemEv3, Inc. · 2011
  • K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  • K071432Silverhawk-R Peripheral Plaque Excision System for Surgical UseFox Hollow Technologies · 2008

More from Ev3, Inc.

35 FDA decisions under this applicant name. See the company

  • K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 20141 recall
  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  • K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  • K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 20111 recall

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/K093301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093301: Turbohawk Peripheral Plaque Excision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093301

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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