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

• • Terminated Z-1091-04 FDA Unclassified (pre-2012) ·initiated 17 Jun 2004 ·on shared 510(k) K024243

  Devices for which sterility may be compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K024243 ↗

FDA Product Code

MCW

Models / Variants

Reform Peripheral Catheter System, Model 02200

Reform Peripheral Cathetercatheter, Model 02406

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

• Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300,

  Class II

  FDA 510(k) K053460 Active Cleared 13 Jan 2006

• 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