Angiojet Ultra Avx Thrombectomy Set

• • Terminated Z-2380-2015 FDA Class II ·initiated 31 Jul 2015 ·on shared 510(k) K133629

  AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

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

510(k) Number

K133629 ↗

FDA Product Code

QEW

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Guarddog Occlusion System

  Class II

  FDA 510(k) K062220 Active Cleared 11 Aug 2006

• Fetch Aspiration Catheter

  Class II

  FDA 510(k) K070363 Active Cleared 11 May 2007

• Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002

  Class II

  FDA 510(k) K993564 Active Cleared 28 Apr 2000

• Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039

  Class II

  FDA 510(k) K071342 Active Cleared 31 Jul 2007

• Angiojet Ultra Dvx Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001

  Class II

  FDA 510(k) K090253 Active Cleared 8 Apr 2009

• Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit

  Class II

  FDA 510(k) K040013 Active Cleared 18 May 2004

See all devices from Possis Medical, Inc. →