# K091626: Cryopatch SG Pulmonary Hemi-Artery; Trunk;  Branch

- Pathway: 510(k) (Traditional)
- Applicant: Cryolife, Inc.
- Decided: Aug 7, 2009 after 65 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K083106 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083106: Cryovalve SG Pulmonary Valve and Conduit, Cryolife, Inc. (2009) Summary page 1.
- (no number) MatrACELL Pulmonary Artery Patch Allograft: named in the summary without a submission number

## Most influential descendants
- K101866: Cryopatch SG Pulmonary Human Cardiac Patch (2010), 0 descendants of its own

## Recalls of this device
- May 28, 2024 · Class II · Z-2532-2024: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- Sep 6, 2018 · Class II · Z-0121-2019: 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.
- Nov 21, 2016 · Class II · Z-1219-2019: 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.

## Indications for use
Indicated for repair or reconstruction of the right ventricular outflow tract.

Source page: https://510kreport.com/device/K091626
Methodology: https://510kreport.com/methodology