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Devices
CryoValve
Model / Serial
Donor #68830, Serial #8038836, Model #PV10
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The tissue was distributed to one physician in CA.
Product Description
CryoValve, Pulmonary Heart Valve
Manufacturer
Cryolife Inc
1 Event
Recall of CryoValve
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Manufacturer
Cryolife Inc
Manufacturer Address
Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144
Source
USFDA
82 devices with a similar name
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Device Recall SynerGraft CryoValve Pulmonary Valve and Conduit SG
Model / Serial
Serial No. 9560908 - Model SGPV00
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including AZ & NV
Product Description
Pulmonary Valve & Conduit SG || Used in heart surgery
Manufacturer
CryoLife, Inc.
CryoValve
Model / Serial
Donor #69884, Serial #8062335, Model #AV00.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The tissues were distributed to one hospital in CA and one physician in MN.
Product Description
CryoValve, Aortic & Conduit
Manufacturer
Cryolife Inc
Device Recall CryoValve
Model / Serial
Donor #69347, Serial #8022177, Model #PV00
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The tissue was distributed to one physician in IN.
Product Description
CryoValve, Pulmonary Valve and Conduit
Manufacturer
Cryolife Inc
Device Recall CryoValve, Allograft
Model / Serial
Donor #60741, Model #SGAV10, Serial #783013
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.
Product Description
Heart-valve, allograft
Manufacturer
Cryolife Inc
Device Recall CryoValve Allograft heart valve
Model / Serial
Model number SGPV00, Serial Number: 7291867, Donor #55899
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
Product Description
CryoValve Allograft heart valve
Manufacturer
Cryolife Inc
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