Medtronic Everest Inflation Device

• • Terminated Z-1121-2014 FDA Class III ·initiated 6 Feb 2014

  Incorrect master label.

• 3 recalls, same reason

  • Terminated Z-2272-2010 FDA Unclassified (pre-2012) ·initiated 16 Jul 2010
  • Terminated Z-2273-2010 FDA Unclassified (pre-2012) ·initiated 16 Jul 2010
  • Terminated Z-2271-2010 FDA Unclassified (pre-2012) ·initiated 16 Jul 2010

  Product sterility may be compromised due to breach of package seal integrity.

• • Terminated Z-0625-03 FDA Unclassified (pre-2012) ·initiated 31 Jan 2003 ·on shared 510(k) K942269

  PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon

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

510(k) Number

K942269 ↗

FDA Product Code

MAV

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Gc IV Coronary Guiding Catheter

  Class II

  FDA 510(k) K932933 Active Cleared 1 Feb 1994

• Medtronic 7F and 8F Zuma Guiding Catheter

  Class II

  FDA 510(k) K982883 Active Cleared 4 Sep 1998

• Medtronic Interventional Vascular Y-Adapter, Tri-Adapter, Tri-Adapter & Accessory Packs

  Class II

  FDA 510(k) K940063 Active Cleared 29 Mar 1994

• Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding Catheter

  Class II

  FDA 510(k) K950026 Active Cleared 5 Apr 1995

• Sherpa Sherpa II and Ascent Coronary Guiding Catheters

  Class II

  FDA 510(k) K944668 Active Cleared 3 Mar 1995

• Medtronic Gciii Coronary Guiding Catheter

  Class II

  FDA 510(k) K935738 Active Cleared 4 May 1994

See all devices from Medtronics Interventional Vascular →