Radius Ptca Guidewire

• 2 recalls, same reason

  • Terminated Z-0267-2014 FDA Class I ·initiated 21 Oct 2013
  • Terminated Z-0263-2014 FDA Class I ·initiated 21 Oct 2013

  Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

510(k) Number

K970466 ↗

FDA Product Code

LIT

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Radius Cougar Wire

  Class II

  FDA 510(k) K032899 Active Cleared 17 Oct 2003

• Radius Snare

  Class II

  FDA 510(k) K021441 Active Cleared 14 Jun 2002

• Modification to Radius Snare

  Class II

  FDA 510(k) K071457 Active Cleared 25 Sep 2007

• Radius 018 Cougar Wire

  Class II

  FDA 510(k) K032129 Active Cleared 17 Jul 2003

• Radius Micro Snare

  Class II

  FDA 510(k) K022201 Active Cleared 3 Feb 2003

• Radius Next Generation Guidewire

  Class II

  FDA 510(k) K011759 Active Cleared 23 Aug 2001

See all devices from Radius Medical Technologies, Inc. →