# K033484: Human Heart Valve, Cryovalve SG

- Pathway: 510(k) (Traditional)
- Applicant: Cryolife, Inc.
- Decided: Feb 7, 2008 after 1,556 days
- Product code: OHA (Heart Valve, More Than Minimally Manipulated Allograft)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Human Heart Valve Allograft - CryoValve: named in the summary without a submission number

## Most influential descendants
- K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit) (2010), 2 descendants 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
- Mar 26, 2008 · Not classified · Z-1523-2008: Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
- Mar 26, 2008 · Not classified · Z-1524-2008: Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.

## 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/K033484
Methodology: https://510kreport.com/methodology