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510(k) K252059

Device
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
Applicant
Artivion, Inc.
510(k) number
K252059
Product code
OHA
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-02
Date received
2025-07-01
Classification name
Heart Valve, More Than Minimally Manipulated Allograft
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Karissa Gleason
Address
1655 Roberts Blvd. NW Kennesaw GA US 30144 30144

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OHA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092021CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)Cryolife, Inc.2010-05-25
K083106CRYOVALVE SG PULMONARY VALVE AND CONDUITCryolife, Inc.2009-02-06
K033484HUMAN HEART VALVE, CRYOVALVE SGCryolife, Inc.2008-02-07