CRYOPATCH SG PULMONARY HEMI-ARTERY - Trunk

• • Ongoing Z-2532-2024 FDA Class II ·initiated 28 May 2024

  Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

• • Terminated Z-0121-2019 FDA Class II ·initiated 6 Sep 2018

  The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

• • Terminated Z-1219-2019 FDA Class II ·initiated 21 Nov 2016

  The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

510(k) Number

K091626 ↗

FDA Product Code

DXZ

Models / Variants

Cryopatch Sg Pulmonary Hemi-Artery

Trunk

Branch

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

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

• 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

• Human Heart Valve, Cryovalve Sg

  Unclassified

  FDA 510(k) K033484 Active Cleared 7 Feb 2008

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