Medtronic, Inc. Racer Biliary Stent System (Racer), Model Xd#yf(L)

• • Terminated Z-1802-2010 FDA Unclassified (pre-2012) ·initiated 30 Jul 2009

  Mislabeling-- The incorrect Instructions for use may have been included with this product.

510(k) Number

K032768 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

• Bridge Se Self-Expanding Stent Delivery System

  Class II

  FDA 510(k) K011080 Active Cleared 11 Oct 2001

• Aurora Biliary Stent System

  Class II

  FDA 510(k) K030839 Active Cleared 30 May 2003

• Medtronic Ave Bridge Constant Biliary Stent System

  Class II

  FDA 510(k) K030633 Active Cleared 2 Sep 2003

• Wire, Guide, Catheter, Model QSW1000

  Class II

  FDA 510(k) K002346 Active Cleared 27 Sep 2000

• Bridge Fx

  Class II

  FDA 510(k) K011817 Active Cleared 22 Aug 2001

• Medtronic Ave Bridge X3 Stent

  Class II

  FDA 510(k) K000744 Active Cleared 5 Jun 2000

See all devices from Medtronic Ave, Inc. →