510(k) · Cleared

Cleared

Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300

K061063510(k) SpecialCleared May 18, 200631-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

Foxhollow Technologies, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on May 18, 2006 as substantially equivalent to K053460 (Fox Hollow Technologies, 2006) after a 31-day review. Its family tree reaches back 4 generations to 1987. 4 of the 45 devices in its family, counting itself, have a Class I recall. 37 later devices descend from it.

Decided: May 18, 2006
Review: 31 days
Class: Class II
Product code: MCW
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K871011 (1987). 7 ancestors in all. 37 later devices descend from it, 3 citing it directly. 4 of the 45 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
3 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
2 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
1 generation backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
This deviceK061063 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
Descendant · 2 generations on · 32 of its ownK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
Descendant · 2 generations on · 28 of its ownK083489 Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009
Descendant · 3 generations on · 28 of its ownK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2008high 6 (2009) · low 0 (2020)2026

Class I recalls in this family

K212027 TurboHawk Plus Directional Atherectomy System2 generations on · 2021
K172315 Straub Endovascular System4 generations on · 2018
K211738 Rotarex Atherectomy System5 generations on · 2021
K242757 Rotarex Atherectomy System6 generations on · 2025

Most influential descendants

Showing 5 of 37 · See all

K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · cites it directly34descendants
K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · 2 generations on33descendants
K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008 · 2 generations on32descendants
K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009 · 2 generations on28descendants
K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc. · 2009 · 3 generations on28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K871011	Simpson Peripheral Atherocath (TM)	Devices For Vascular Intervention, Inc.	1987	—
−3	K024243	Reform Peripheral Catheter System, Model 02200; Reform Peripheral…	Fox Hollow Technologies	2003	1
−2	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	—
0 (this device)	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	—
+2	K082664	Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100	Pathway Medical Technologies, Inc.	2008	—
+2	K083489	Jetstream Pathway PC Atherectomy System, Model OV10300	Pathway Medical Technologies, Inc.	2009	—
+3	K083837	Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…	Pathway Medical Technologies, Inc.	2009	—

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
2008	3	0
2009	6	0
2010	4	0
2011	3	0
2012	2	0
2013	1	0
2014	4	0
2015	1	0
2016	1	0
2017	2	0
2018	3	1
2019	1	0
2021	5	2
2025	1	1

FIG. 1 — Lineage of K061063, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

4 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K053460	Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800… Summary page 1 …ietary Name: SilverHawk tm Peripheral Plaque Excision System Predicate Device The SilverHawk tm Peripheral Plaque Excision System (K053460), currently marketed by FoxHollow Technologies, Inc. (Redwood City, CA). Summary This summary…	Fox Hollow Technologies	2006	—

Also cleared against K053460: 3 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K081328	Pathway PV Atherectomy System	Pathway Medical Technologies, Inc.	2008	34
K132682	Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…	Atheromed, Inc.	2014	6
K170191	SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System	Medtronic Vascular, Inc.	2017	1

Has anything in its family been recalled? (4 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.

K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 12 Class I recalls
K172315Straub Endovascular SystemStraub Medical AG · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
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

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
1 of the 7 ancestors has a recall of any class.
Of its descendants, K081328 (Pathway Medical Technologies, Inc., 2008) has gone furthest, with 34 descendants of its own.
3 other devices also cite its predicate K053460.

How does its category compare?

All MCW devices

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

FDA decisions per year · MCW

3in 2025

2007high 8 (2009) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCW

46in 2025

2007high 119 (2021) · low 27 (2009)2026

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

Recalls per year · MCW

2in 2024

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

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

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 SilverHawkTM 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061063 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061063: Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061063

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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