510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061063Substantially Equivalent

Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/fg08300

Foxhollow Technologies, Inc., Redwood City CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061063 is the FDA 510(k) clearance record for MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300, a class II device, cleared for Foxhollow Technologies, Inc. on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 2 510(k) clearances for Foxhollow Technologies, Inc., from to . As of , FDA records show no recalls naming K061063.

Clearance record

Decision date
Received
(31 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Foxhollow Technologies, Inc. 740 Bay Rd., Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MCW

Trailing 12 months
1 clearance under product code MCW in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260