Modification to Outback Catheter

• • Terminated Z-0279-2009 FDA Unclassified (pre-2012) ·initiated 20 Aug 2008 ·on shared 510(k) K043534

  The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula.

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

510(k) Number

K043534 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Outback Catheter

  Class II

  FDA 510(k) K040771 Active Cleared 23 Apr 2004

• Modification to Lumend Frontrunner Cto Catheter

  Class II

  FDA 510(k) K023223 Active Cleared 24 Oct 2002

• Lumend Frontrunner Cto Coronary Catheter

  Class II

  FDA 510(k) K013284 Active Cleared 11 Feb 2002

• Lumend Percutaneous Catheter

  Class II

  FDA 510(k) K011562 Active Cleared 16 Jan 2002

• Outback Catheter

  Class II

  FDA 510(k) K032298 Active Cleared 26 Aug 2003

• Lumend Frontrunner Cto Catheter

  Class II

  FDA 510(k) K023114 Active Cleared 23 Jan 2003

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