510(k) · Cleared
ClearedSilverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fox Hollow Technologies · MCW Catheter, Peripheral, Atherectomy
Cleared on Feb 18, 2005 as substantially equivalent to K024243 (Fox Hollow Technologies, 2003) after a 53-day review. Its family tree reaches back 2 generations to 1987. 6 of the 85 devices in its family, counting itself, have a Class I recall. 79 later devices descend from it.
- Decided
- Feb 18, 2005
- Review
- 53 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871011 (1987). 5 ancestors in all. 79 later devices descend from it, 4 citing it directly. 6 of the 85 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 1 generation backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- This deviceK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- Descendant · cites it directly · 52 of its ownK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- Descendant · 2 generations on · 50 of its ownK061188 Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 37 of its ownK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- Descendant · cites it directly · 34 of its ownK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 33 of its ownK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 79 · See all- K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…Fox Hollow Technologies · 2006 · cites it directly52descendants
- K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · 2 generations on50descendants
- K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Foxhollow Technologies, Inc. · 2006 · 2 generations on37descendants
- K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · cites it directly34descendants
- K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −1 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| 0 (this device) | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| +1 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| +2 | K061188 | Silverhawk Peripheral Plaque Excision System | Foxhollow Technologies, Inc. | 2006 | 1 |
| +2 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| +1 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| +2 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 1 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 1 |
| 2017 | 4 | 0 |
| 2018 | 6 | 1 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 2 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 1 |
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.
6 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 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter…Summary page 1…r, Peripheral, Atherectomy ProprietaryName: SilverHawk Peripheral Plaque Excision System Predicate Device The ReFORM Peripheral Catheter System (K024243), currently marketed by FoxHollow Technologies, Inc. (Redwood City, CA). Summary This summary of Special 5 10(k) safety and effec… | 2003 |
| † | K871011 | Simpson Peripheral Atherocath (TM) | 1987 |
| † | K874706 | Modified Simpson Peripheral Atherocath | 1988 |
| † | K881088 | Addition of a Tip Guard to the Atherocath (TM) | 1988 |
| † | K883346 | Simpson Peripheral Atherocath W/Addit. Size 13F | 1988 |
What descends from it? (79)
See all 794 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800… | 2006 | 52 |
| K081328 | Pathway PV Atherectomy System | 2008 | 34 |
| K071350 | Diamondback 360 Degree Orbital Atherectomy System | 2007 | 28 |
| K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter… | 2014 | 6 |
Has anything in its family been recalled? (6 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.
- K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 12 Class I recalls
- K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 16.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K053460 (Fox Hollow Technologies, 2006) has gone furthest, with 52 descendants of its own.
- 3 other devices also cite its predicate K024243.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature. The intended use of the SilverHawk Peripheral Plaque Excision System is identical to the approved indication for the ReForm Peripheral Catheter System which was found to be substantially equivalent to the Simpson Peripheral Atherocath (K871011, K874706, K881088 and…
Read the full statement (102 words)
The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.
The intended use of the SilverHawk Peripheral Plaque Excision System is identical to the approved indication for the ReForm Peripheral Catheter System which was found to be substantially equivalent to the Simpson Peripheral Atherocath (K871011, K874706, K881088 and K883346). Both the SilverHawk Peripheral Plaque Excision System and the ReForm Peripheral Catheter System are designed for atherectomy of the peripheral vasculature and neither device is intended for use in the coronary or carotid vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043553: Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043553
Report an extraction error
Are you the manufacturer?
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