ClearanceBrief
Company ยท US

Artivion, Inc

FDA 510(k) clearances and medical device recalls filed under this name, 2025 to 2025. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
4recalls (1 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
OHAHeart Valve, More Than Minimally Manipulated Allograft3
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 2, 2025K252059CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
Artivion, Inc.
OHA

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 30, 2026Artivion, Inc
CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
Open, Classified		 DXZK101866
Aug 8, 2024Artivion, Inc
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmona
Open, Classified		 DXZK091626
Aug 8, 2024Artivion, Inc
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Open, Classified		 OHAK092021
Apr 16, 2024Artivion, Inc
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Open, Classified		 OHAK092021
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