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Devices
Device Recall CryoValve
Model / Serial
Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve)
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The allograft was shipped to one physician in TX.
Product Description
CryoValve Pulmonary Valve and Conduit
Manufacturer
Cryolife Inc
1 Event
Recall of Device Recall CryoValve
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Manufacturer
Cryolife Inc
Manufacturer Address
Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
Source
USFDA
29 devices with a similar name
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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
Device Recall CryoValve Allograft heart valve
Model / Serial
Model number PV00, Serial Number: 7255205, Donor #56190
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved.
Product Description
CryoValve Allograft heart valve
Manufacturer
Cryolife Inc
Device Recall Cryovalve(R) SG Pulmonary Human Heart Valve
Model / Serial
Serial Number 10988203
Product Classification
Cardiovascular Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
AR, OH
Product Description
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Manufacturer
CryoLife, Inc.
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