SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

Catheter, Peripheral, Atherectomy

FOXHOLLOW TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Foxhollow Technologies, Inc. with the FDA for Silverhawk Peripheral Plaque Excision System.

Pre-market Notification Details

• Device ID: K061188
• 510k Number: K061188
• Device Name: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
• Classification: Catheter, Peripheral, Atherectomy
• Applicant: FOXHOLLOW TECHNOLOGIES, INC. 740 BAY ROAD Redwood City, CA 94063
• Contact: Melissa S Murphy
• Correspondent: Melissa S Murphy; FOXHOLLOW TECHNOLOGIES, INC. 740 BAY ROAD Redwood City, CA 94063
• Product Code: MCW
• CFR Regulation Number: 870.4875 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-28
• Decision Date: 2006-10-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821684074176	K061188	000
00821684074169	K061188	000
00821684074145	K061188	000
00821684074121	K061188	000
00821684074107	K061188	000
00821684074084	K061188	000
00821684074060	K061188	000
00821684074046	K061188	000
00821684074039	K061188	000