# K083106: Cryovalve SG Pulmonary Valve and Conduit

- Pathway: 510(k) (Traditional)
- Applicant: Cryolife, Inc.
- Decided: Feb 6, 2009 after 109 days
- Product code: OHA (Heart Valve, More Than Minimally Manipulated Allograft)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K033484: Human Heart Valve, Cryovalve SG, Cryolife, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit) (2010), 2 descendants of its own
- K091626: Cryopatch SG Pulmonary Hemi-Artery; Trunk;  Branch (2009), 1 descendant of its own
- K252059: CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (2025), 0 descendants of its own
- K101866: Cryopatch SG Pulmonary Human Cardiac Patch (2010), 0 descendants of its own

## Recalls of this device
- Jan 7, 2011 · Not classified · Z-1219-2011: A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.

## Indications for use
CryoValve® SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may, also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

Source page: https://510kreport.com/device/K083106
Methodology: https://510kreport.com/methodology