Cordis Powerflex Extreme PTA Balloon Catheter, Cordis Powerflex Plus PTA Balloon Catheter, Cordis Powerflex P3 PTA

• • Terminated Z-1477-2020 FDA Class II ·initiated 8 Jan 2020 ·on shared 510(k) K032737

  Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

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

510(k) Number

K032737 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System

  Class II

  FDA 510(k) K012056 Active Cleared 1 Aug 2001

• Cordis Aviator Plus PTA Balloon Dilatation Catheter

  Class II

  FDA 510(k) K071189 Active Cleared 16 May 2007

• Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System

  Class II

  FDA 510(k) K040413 Active Cleared 21 Jun 2004

• Cordis Amila Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter

  Class II

  FDA 510(k) K063563 Active Cleared 7 Mar 2007

• Inscope Precision Balloon Dilator - Wire Guided

  Class II

  FDA 510(k) K060302 Active Cleared 11 Apr 2006

• Inscope 3-Stage Balloon Dilator

  Class II

  FDA 510(k) K043605 Active Cleared 4 Feb 2005