MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM - 06002

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K053460 ↗

FDA Product Code

MCW

Models / Variants

02550

04800

05200

06002

02406

04706

04300

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• The Rinspirator, Models FG09770, FG08776, FG08777, FG08910

  Class II

  FDA 510(k) K071826 Active Cleared 9 Nov 2007

• Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406

  Class II

  FDA 510(k) K024243 Active Cleared 20 Jun 2003

• Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 02406, 04706, 04300

  Class II

  FDA 510(k) K043553 Active Cleared 18 Feb 2005

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

  Class II

  FDA 510(k) K061063 Active Cleared 18 May 2006

• Silverhawk-R Peripheral Plaque Excision System for Surgical Use

  Class II

  FDA 510(k) K071432 Active Cleared 12 Feb 2008

• Silverhawk Peripheral Plaque Excision System

  Class II

  FDA 510(k) K061188 Active Cleared 23 Oct 2006