Atlas FDA

ZENITH TX2 TAA ENDOVASCULAR GRAFT

FDA premarket approval P070016/S004 · decided 2009-05-21

Approval details

PMA number
P070016
Supplement
S004
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ZENITH TX2 TAA ENDOVASCULAR GRAFT
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Applicant
William Cook Europe Aps
Date received
2009-04-06
Decision date
2009-05-21
Days to decision
45 days
Decision code
APPR
Product code
MIH
Advisory committee
Cardiovascular
Expedited review
No
Location
Bjaeverskov
Statement
APPROVAL FOR MINOR CHANGES TO THE PROXIMAL TRIGGER-WIRE ATTACHMENT AND TAPERED SECTION OF THE PUSHER.

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510(k) clearances by this applicant

RecordFirmDate
Lunderquist Extra Stiff Wire Guide (K251596)William Cook Europe Aps2025-11-09
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (K251499)William Cook Europe Aps2025-06-11
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter (K233680)William Cook Europe Aps2024-01-18
Lunderquist Extra Stiff Wire Guide (K220137)William Cook Europe Aps2022-02-17
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211874)William Cook Europe Aps2021-07-28
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211875)William Cook Europe Aps2021-07-28
Lunderquist Extra Stiff Wire Guide (K171513)William Cook Europe Aps2017-12-07
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172557)William Cook Europe Aps2017-11-20