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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heart Valve, More Than Minimally Manipulated Allograft
510(k) Number K252059
Device Name CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
Applicant
Artivion, Inc.
1655 Roberts Blvd. NW
Kennesaw,  GA  30144
Applicant Contact Karissa Gleason
Correspondent
Artivion, Inc.
1655 Roberts Blvd. NW
Kennesaw,  GA  30144
Correspondent Contact Karissa Gleason
Classification Product Code
OHA  
Date Received07/01/2025
Decision Date 10/02/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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