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WILLIAM COOK EUROPE APS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028084863002808486WILLIAM COOK EUROPE APS1N2026-01-01SANDET 6 BJAEVERSKOV Sjaelland DK DK-4632

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00827002236455COOK - G23645+1(812)330-5494sharedservices@cookmedical.com
00827002236462COOK - G23646+1(812)330-5494sharedservices@cookmedical.com
00827002483033COOK - G48303+1(812)330-5494sharedservices@cookmedical.com
00827002535176COOK - G53517+1(812)330-5494sharedservices@cookmedical.com
00827002599109Zenith Alpha - Zenith Alpha 2, Thoracic Endovascular Graft Proximal Component+1(812)330-5494sharedservices@cookmedical.com
00827002599123Zenith Alpha - Zenith Alpha 2, Thoracic Endovascular Graft Proximal Component+1(812)330-5494sharedservices@cookmedical.com
00827002599154Zenith Alpha - Zenith Alpha 2, Thoracic Endovascular Graft Proximal Component+1(812)330-5494sharedservices@cookmedical.com
00827002599185Zenith Alpha - Zenith Alpha 2, Thoracic Endovascular Graft Proximal Component+1(812)330-5494sharedservices@cookmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
212271827532450P180001Zenith Dissection Endovascular SystemMIH2018-12-31
212271394671260P140016ZENITH ALPHA THORACIC ENDOVASCULAR GRAFTMIH2015-09-15
212271498027741P100028FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMNIN2011-01-14
212271373879179P070016ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEMMIH2008-05-21
212271013213748K251596Lunderquist Extra Stiff Wire GuideDQX2025-11-09
212271125759453K251499Frova 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)BTR2025-06-11
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 code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX32025-11-09
DTK32024-01-18
BTR22025-06-11
MIH22018-12-31
KRD12015-12-18
MIH 12015-09-15
NIN 12011-01-14

PMA#

PMN#

GUDID#

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