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510(k) K252059

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) by Artivion, Inc. — Product Code OHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2025
Date Received
July 1, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heart Valve, More Than Minimally Manipulated Allograft
Device Class
Class U
Regulation Number
Review Panel
CV
Submission Type

For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.

Other clearances for product code OHA

  • K092021 — CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (May 25, 2010)
  • K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT (February 6, 2009)
  • K033484 — HUMAN HEART VALVE, CRYOVALVE SG (February 7, 2008)