Modification to: Amphirion Deep 0.014 Otw PTA Balloon Catheter

• • Terminated Z-0243-2016 FDA Class II ·initiated 23 Oct 2015

  Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.

510(k) Number

K052791 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Admiral Xtreme PTA Catheter

  Class II

  FDA 510(k) K062809 Active Cleared 18 Oct 2006

• Modification to Amphirion Deep 0.014 Otw PTA Balloon Catheter

  Class II

  FDA 510(k) K050073 Active Cleared 11 Feb 2005

• Diver C.E. Catheter

  Class II

  FDA 510(k) K050276 Active Cleared 7 Mar 2005

• Amphirion Deep 0.014 Otw PTA Balloon Catheter

  Class II

  FDA 510(k) K083919 Active Cleared 13 Mar 2009

• Sailor Plus Percutaneous Transluminal Angioplasty (PTA) Catheter, Model Saexxxxxxxxx

  Class II

  FDA 510(k) K042538 Active Cleared 8 Nov 2004

• Skipper and Skipper Race Guidewire

  Class II

  FDA 510(k) K050756 Active Cleared 5 May 2005

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