Cryovalve Sg Pulmonary Valve and Conduit

• • Terminated Z-1219-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011 ·via K083106, on the same 510(k)

  A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K083106 ↗

FDA Product Code

OHA

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• PhotoFix Decellularized Bovine Pericardium

  Class II

  FDA 510(k) K183635 Active Cleared 14 Feb 2019

• Cryovalve Sg Pulmonary Human Heart Valve (and Conduit) Open recall

  Unclassified

  FDA 510(k) K092021 Active Cleared 25 May 2010

• Cryopatch Sg Pulmonary Hemi-Artery; Trunk; Branch Open recall

  Class II

  FDA 510(k) K091626 Active Cleared 7 Aug 2009

• Perclot Topical

  Unclassified

  FDA 510(k) K132105 Active Cleared 3 Apr 2014

• Cryopatch Sg Pulmonary Human Cardiac Patch

  Class II

  FDA 510(k) K101866 Active Cleared 23 Jul 2010

• Propatch Soft Tissue Repair Matrix

  Class II

  FDA 510(k) K061892 Active Cleared 22 Nov 2006

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