FDA.report

WILLIAM COOK EUROPE APS

Matched from indexed company URL: William Cook Europe ApS

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30028084863002808486WILLIAM COOK EUROPE APS1N2026-01-01SANDET 6 BJAEVERSKOV Sjalland DK DK-4632

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
212271827532450P180001Zenith Dissection Endovascular SystemMIH2018-12-31
212271394671260P140016ZENITH ALPHA THORACIC ENDOVASCULAR GRAFTMIH 2015-09-15
212271498027741P100028FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMNIN 2011-01-14
212271373879179P070016ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEMMIH2008-05-21
212271160880786K233680Celect 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 FilterDTK2024-01-18
212271130055442K220137Lunderquist Extra Stiff Wire GuideDQX2022-02-17
212271345059336K172557Gunther 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 ApproachDTK2017-11-20
212271309396333K171712Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachDTK2017-08-07
212271178827520K171513Lunderquist Extra Stiff Wire GuideDQX2017-12-07
212271995882414K161813Frova Intubating IntroducerBTR2017-05-19
212271541559103K150964MReye Flipper Detachable Embolization Coil and Delivery SystemKRD2015-12-18

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DTK32024-01-18
DQX22022-02-17
MIH22018-12-31
BTR12017-05-19
KRD12015-12-18
MIH 12015-09-15
NIN 12011-01-14

PMA

Zenith Dissection Endovascular System

2022-09-01

WILLIAM COOK EUROPE APSsandet 6, Dk-4632bjaeverskov  PMA NumberP180001 Supplement NumberS006 Date Received06/06/2022 Decision Date09/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design...

Zenith Dissection Endovascular System

2022-06-02

WILLIAM COOK EUROPE APSsandet 6, Dk-4632bjaeverskov  PMA NumberP180001 Supplement NumberS005 Date Received05/05/2022 Decision Date06/02/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Label...

Zenith Dissection Endovascular System

2022-04-14

WILLIAM COOK EUROPE APSsandet 6, Dk-4632bjaeverskov  PMA NumberP180001 Supplement NumberS004 Date Received03/18/2022 Decision Date04/14/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Proce...

PMN

Applications

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