Angiojet Xmi Catheter - Rapid Exchange (Xmi-Rx)

• • Terminated Z-0955-2007 FDA Unclassified (pre-2012) ·initiated 1 May 2007 ·on shared 510(k) K042874

  Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

• • Terminated Z-0469-06 FDA Unclassified (pre-2012) ·initiated 12 Dec 2005 ·on shared 510(k) K042874

  It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.

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

510(k) Number

K042874 ↗

FDA Product Code

QEZ

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

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