# K252059: CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

- Pathway: 510(k) (Special)
- Applicant: Artivion, Inc.
- Decided: Oct 2, 2025 after 93 days
- Product code: OHA (Heart Valve, More Than Minimally Manipulated Allograft)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033484 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit), Cryolife, Inc. (2010) Summary page 5.

## 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/K252059
Methodology: https://510kreport.com/methodology