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Devices
Zenith Flex AAA
Model / Serial
F2628865
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
US, Canada, Japan
Product Description
Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432, 22 Fr ID/ 8.5 mm OD, Sterile.
Manufacturer
Cook, Inc.
1 Event
Recall of Zenith Flex AAA
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Manufacturer
Cook, Inc.
Manufacturer Address
Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
Source
USFDA
57 devices with a similar name
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Zenith Flex AAA Endovascular Graft Bifurcated Main Body
Model / Serial
TFFB
Product Description
MD: Vascular prosthesis
Manufacturer
Cook Incorporated
ZENITH FLEX AAA ENDOVASCULAR GRAFT-BIFURCATED MAIN BODY GRAFT (TFFB SERIES)
Model / Serial
Model Catalog: TFFB-26-111 (Lot serial: 1436829)
Product Description
ZENITH FLEX AAA ENDOVASCULAR GRAFT
Manufacturer
COOK (CANADA) INC.
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System ( A= 2...
Model / Serial
All units distributed on or before 12/17/04.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide and Canada.
Product Description
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System ( A= 22mm, B=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-82.
Manufacturer
Cook, Inc.
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 24...
Model / Serial
All units distributed on or before 12/17/04.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide and Canada.
Product Description
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 24mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-82.
Manufacturer
Cook, Inc.
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 26...
Model / Serial
All units distributed on or before 12/17/04.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide and Canada.
Product Description
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 26mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-82.
Manufacturer
Cook, Inc.
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