Atlas FDA

Zenith Dissection Endovascular System

FDA premarket approval P180001/S005 · decided 2022-06-02

Approval details

PMA number
P180001
Supplement
S005
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Zenith Dissection Endovascular System
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Applicant
William Cook Europe Aps
Date received
2022-05-05
Decision date
2022-06-02
Days to decision
28 days
Decision code
APPR
Product code
MIH
Advisory committee
Cardiovascular
Expedited review
No
Location
Bjaeverskov
Statement
Approval for updating the Instructions for Use to report the theoretical (i.e., calculated) maximum length for the Zenith Dissection Endovascular Stent.

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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