Diver C.E. Catheter

• • Terminated Z-1517-2013 FDA Class II ·initiated 4 Mar 2009 ·on shared 510(k) K050276

  Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

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

510(k) Number

K050276 ↗

FDA Product Code

QEZ

Device Class

Class II

Regulation

21 CFR Part 870.5150

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

• Amphirion Deep 0.014 Otw PTA Balloon Catheter

  Class II

  FDA 510(k) K083919 Active Cleared 13 Mar 2009

• Diver C.E. Catheter

  Class II

  FDA 510(k) K051917 Active Cleared 8 Aug 2005

• Modification to: Amphirion Deep 0.014 Otw PTA Balloon Catheter

  Class II

  FDA 510(k) K052791 Active Cleared 4 Nov 2005

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

  Class II

  FDA 510(k) K042538 Active Cleared 8 Nov 2004

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