William Cook Europe A P S

FDA Filings

This page includes the latest FDA filings for William Cook Europe A P S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3002808486
• FEI Number: 3002808486
• Name: APRIL LAVENDER
• Owner & Operator: WILLIAM COOK EUROPE APS
• Contact Address: SANDET 6, DK-4632 --; BJAEVERSKOV DK-NOTA -- DK
• US Agent:
  • APRIL LAVENDER
  • COOK, INC.
  • 812 3392235
  • 812 3320281
  • APRIL.LAVENDER@COOKMEDICAL.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 750 Daniels Way ; BLOOMINGTON, IN 47404 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K220137 William Cook Europe ApS	Lunderquist Extra Stiff Wire Guide	2022-02-17
PMA P180001S003 WILLIAM COOK EUROPE APS	Zenith® Dissection Endovascular System	2021-12-15
PMN K211875 William Cook Europe ApS	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	2021-07-28
PMN K211874 William Cook Europe ApS	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	2021-07-28
PMA P180001S002 WILLIAM COOK EUROPE APS	Zenith Dissection Endovascular System	2021-03-31
GUDID 10827002355269 William Cook Europe ApS	Zenith Alpha ZTA-DE-40-141-W	2021-02-05
GUDID 10827002355252 William Cook Europe ApS	Zenith Alpha ZTA-DE-40-91-W	2021-02-05
GUDID 10827002355245 William Cook Europe ApS	Zenith Alpha ZTA-DE-38-141-W	2021-02-05
GUDID 10827002355238 William Cook Europe ApS	Zenith Alpha ZTA-DE-38-91-W	2021-02-05
GUDID 10827002355221 William Cook Europe ApS	Zenith Alpha ZTA-DE-36-160-W	2021-02-05
GUDID 10827002355214 William Cook Europe ApS	Zenith Alpha ZTA-DE-36-112-W	2021-02-05
GUDID 10827002355207 William Cook Europe ApS	Zenith Alpha ZTA-DE-34-160-W	2021-02-05
GUDID 10827002355191 William Cook Europe ApS	Zenith Alpha ZTA-DE-34-112-W	2021-02-05
GUDID 10827002355184 William Cook Europe ApS	Zenith Alpha ZTA-DE-32-154-W	2021-02-05
GUDID 10827002355177 William Cook Europe ApS	Zenith Alpha ZTA-DE-32-108-W	2021-02-05
GUDID 10827002355160 William Cook Europe ApS	Zenith Alpha ZTA-DE-30-154-W	2021-02-05
GUDID 10827002355153 William Cook Europe ApS	Zenith Alpha ZTA-DE-30-108-W	2021-02-05
GUDID 10827002355146 William Cook Europe ApS	Zenith Alpha ZTA-DE-28-154-W	2021-02-05
GUDID 10827002355139 William Cook Europe ApS	Zenith Alpha ZTA-DE-28-108-W	2021-02-05
GUDID 10827002355122 William Cook Europe ApS	Zenith Alpha ZTA-DE-26-148-W	2021-02-05
GUDID 10827002355115 William Cook Europe ApS	Zenith Alpha ZTA-DE-26-104-W	2021-02-05
GUDID 10827002355108 William Cook Europe ApS	Zenith Alpha ZTA-DE-24-148-W	2021-02-05
GUDID 10827002355092 William Cook Europe ApS	Zenith Alpha ZTA-DE-24-104-W	2021-02-05
GUDID 10827002355078 William Cook Europe ApS	Zenith Alpha ZTA-DE-22-148-W	2021-02-05
GUDID 10827002355061 William Cook Europe ApS	Zenith Alpha ZTA-DE-22-104-W	2021-02-05
GUDID 10827002355054 William Cook Europe ApS	Zenith Alpha ZTA-DE-20-148-W	2021-02-05
GUDID 10827002355047 William Cook Europe ApS	Zenith Alpha ZTA-DE-20-104-W	2021-02-05
GUDID 10827002355030 William Cook Europe ApS	Zenith Alpha ZTA-DE-18-148-W	2021-02-05
GUDID 10827002355023 William Cook Europe ApS	Zenith Alpha ZTA-DE-18-104-W	2021-02-05
GUDID 10827002354040 William Cook Europe ApS	Zenith Alpha ZTA-D-46-211-W	2021-02-05
GUDID 10827002354033 William Cook Europe ApS	Zenith Alpha ZTA-D-46-157-W	2021-02-05
GUDID 10827002354026 William Cook Europe ApS	Zenith Alpha ZTA-D-44-211-W	2021-02-05
GUDID 10827002354019 William Cook Europe ApS	Zenith Alpha ZTA-D-44-157-W	2021-02-05
GUDID 10827002354002 William Cook Europe ApS	Zenith Alpha ZTA-D-42-204-W	2021-02-05
GUDID 10827002353999 William Cook Europe ApS	Zenith Alpha ZTA-D-42-152-W	2021-02-05
GUDID 10827002353982 William Cook Europe ApS	Zenith Alpha ZTA-D-40-197-W	2021-02-05
GUDID 10827002353975 William Cook Europe ApS	Zenith Alpha ZTA-D-40-147-W	2021-02-05
GUDID 10827002353968 William Cook Europe ApS	Zenith Alpha ZTA-D-38-197-W	2021-02-05
GUDID 10827002353951 William Cook Europe ApS	Zenith Alpha ZTA-D-38-147-W	2021-02-05
GUDID 10827002353944 William Cook Europe ApS	Zenith Alpha ZTA-D-36-190-W	2021-02-05
GUDID 10827002353937 William Cook Europe ApS	Zenith Alpha ZTA-D-36-142-W	2021-02-05
GUDID 10827002353920 William Cook Europe ApS	Zenith Alpha ZTA-D-34-190-W	2021-02-05
GUDID 10827002353913 William Cook Europe ApS	Zenith Alpha ZTA-D-34-142-W	2021-02-05
GUDID 10827002353869 William Cook Europe ApS	Zenith Alpha ZTA-D-32-229-W	2021-02-05
GUDID 10827002353852 William Cook Europe ApS	Zenith Alpha ZTA-D-32-160-W	2021-02-05
GUDID 10827002353845 William Cook Europe ApS	Zenith Alpha ZTA-D-30-229-W	2021-02-05
GUDID 10827002353838 William Cook Europe ApS	Zenith Alpha ZTA-D-30-160-W	2021-02-05
GUDID 10827002353821 William Cook Europe ApS	Zenith Alpha ZTA-D-28-229-W	2021-02-05
GUDID 10827002353814 William Cook Europe ApS	Zenith Alpha ZTA-D-28-160-W	2021-02-05
GUDID 10827002353760 William Cook Europe ApS	Zenith Alpha ZTA-P-46-233-W	2021-02-05
GUDID 10827002353753 William Cook Europe ApS	Zenith Alpha ZTA-P-46-179-W	2021-02-05
GUDID 10827002353746 William Cook Europe ApS	Zenith Alpha ZTA-P-46-152-W	2021-02-05
GUDID 10827002353739 William Cook Europe ApS	Zenith Alpha ZTA-P-46-125-W	2021-02-05
GUDID 10827002353722 William Cook Europe ApS	Zenith Alpha ZTA-P-44-233-W	2021-02-05
GUDID 10827002353715 William Cook Europe ApS	Zenith Alpha ZTA-P-44-179-W	2021-02-05
GUDID 10827002353708 William Cook Europe ApS	Zenith Alpha ZTA-P-44-152-W	2021-02-05
GUDID 10827002353692 William Cook Europe ApS	Zenith Alpha ZTA-P-44-125-W	2021-02-05
GUDID 10827002353685 William Cook Europe ApS	Zenith Alpha ZTA-P-42-225-W	2021-02-05
GUDID 10827002353678 William Cook Europe ApS	Zenith Alpha ZTA-P-42-173-W	2021-02-05
GUDID 10827002353661 William Cook Europe ApS	Zenith Alpha ZTA-P-42-147-W	2021-02-05
GUDID 10827002353654 William Cook Europe ApS	Zenith Alpha ZTA-P-42-121-W	2021-02-05
GUDID 10827002353647 William Cook Europe ApS	Zenith Alpha ZTA-P-40-217-W	2021-02-05
GUDID 10827002353630 William Cook Europe ApS	Zenith Alpha ZTA-P-40-167-W	2021-02-05
GUDID 10827002353623 William Cook Europe ApS	Zenith Alpha ZTA-P-40-142-W	2021-02-05
GUDID 10827002353616 William Cook Europe ApS	Zenith Alpha ZTA-P-40-117-W	2021-02-05
GUDID 10827002353609 William Cook Europe ApS	Zenith Alpha ZTA-P-38-217-W	2021-02-05
GUDID 10827002353593 William Cook Europe ApS	Zenith Alpha ZTA-P-38-167-W	2021-02-05
GUDID 10827002353586 William Cook Europe ApS	Zenith Alpha ZTA-P-38-142-W	2021-02-05
GUDID 10827002353579 William Cook Europe ApS	Zenith Alpha ZTA-P-38-117-W	2021-02-05
GUDID 10827002353562 William Cook Europe ApS	Zenith Alpha ZTA-P-36-209-W	2021-02-05
GUDID 10827002353555 William Cook Europe ApS	Zenith Alpha ZTA-P-36-161-W	2021-02-05
GUDID 10827002353548 William Cook Europe ApS	Zenith Alpha ZTA-P-36-137-W	2021-02-05
GUDID 10827002353531 William Cook Europe ApS	Zenith Alpha ZTA-P-36-113-W	2021-02-05
GUDID 10827002353524 William Cook Europe ApS	Zenith Alpha ZTA-P-34-209-W	2021-02-05
GUDID 10827002353517 William Cook Europe ApS	Zenith Alpha ZTA-P-34-161-W	2021-02-05
GUDID 10827002353500 William Cook Europe ApS	Zenith Alpha ZTA-P-34-137-W	2021-02-05
GUDID 10827002353494 William Cook Europe ApS	Zenith Alpha ZTA-P-34-113-W	2021-02-05
GUDID 10827002353487 William Cook Europe ApS	Zenith Alpha ZTA-P-32-201-W	2021-02-05
GUDID 10827002353470 William Cook Europe ApS	Zenith Alpha ZTA-P-32-155-W	2021-02-05
GUDID 10827002353463 William Cook Europe ApS	Zenith Alpha ZTA-P-32-132-W	2021-02-05
GUDID 10827002353456 William Cook Europe ApS	Zenith Alpha ZTA-P-32-109-W	2021-02-05
GUDID 10827002353449 William Cook Europe ApS	Zenith Alpha ZTA-P-30-201-W	2021-02-05
GUDID 10827002353432 William Cook Europe ApS	Zenith Alpha ZTA-P-30-155-W	2021-02-05
GUDID 10827002353425 William Cook Europe ApS	Zenith Alpha ZTA-P-30-132-W	2021-02-05
GUDID 10827002353418 William Cook Europe ApS	Zenith Alpha ZTA-P-30-109-W	2021-02-05
GUDID 10827002353401 William Cook Europe ApS	Zenith Alpha ZTA-P-28-201-W	2021-02-05
GUDID 10827002353395 William Cook Europe ApS	Zenith Alpha ZTA-P-28-155-W	2021-02-05
GUDID 10827002353388 William Cook Europe ApS	Zenith Alpha ZTA-P-28-132-W	2021-02-05
GUDID 10827002353371 William Cook Europe ApS	Zenith Alpha ZTA-P-28-109-W	2021-02-05
GUDID 10827002353364 William Cook Europe ApS	Zenith Alpha ZTA-P-26-149-W	2021-02-05
GUDID 10827002353357 William Cook Europe ApS	Zenith Alpha ZTA-P-26-105-W	2021-02-05
GUDID 10827002353340 William Cook Europe ApS	Zenith Alpha ZTA-P-24-127-W	2021-02-05
GUDID 10827002353333 William Cook Europe ApS	Zenith Alpha ZTA-P-24-105-W	2021-02-05
GUDID 10827002353326 William Cook Europe ApS	Zenith Alpha ZTA-P-22-127-W	2021-02-05
GUDID 10827002353319 William Cook Europe ApS	Zenith Alpha ZTA-P-22-105-W	2021-02-05
GUDID 10827002353302 William Cook Europe ApS	Zenith Alpha ZTA-P-20-127-W	2021-02-05
GUDID 10827002353296 William Cook Europe ApS	Zenith Alpha ZTA-P-20-105-W	2021-02-05
GUDID 10827002353289 William Cook Europe ApS	Zenith Alpha ZTA-P-18-127-W	2021-02-05
GUDID 10827002353272 William Cook Europe ApS	Zenith Alpha ZTA-P-18-105-W	2021-02-05
GUDID 10827002185286 William Cook Europe ApS	Formula FORX414-14-135-4-20	2021-02-05
GUDID 10827002185279 William Cook Europe ApS	Formula FORX414-14-135-4-16	2021-02-05
GUDID 10827002185262 William Cook Europe ApS	Formula FORX414-14-135-4-12	2021-02-05
GUDID 10827002185255 William Cook Europe ApS	Formula FORX414-14-80-4-20	2021-02-05
GUDID 10827002185248 William Cook Europe ApS	Formula FORX414-14-80-4-16	2021-02-05
GUDID 10827002185231 William Cook Europe ApS	Formula FORX414-14-80-4-12	2021-02-05
PMA P180001S001 WILLIAM COOK EUROPE APS	Zenith Dissection Endovascular System	2019-10-31
PMN K172557 | DTK APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach	2019-02-04
PMN K172557 | DTK APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach	2019-02-04
PMN K172557 | DTK APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach	2019-02-04
PMN K171712 | DTK APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach	2019-02-04
PMN K171712 | DTK APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach	2019-02-04
PMN K171712 | DTK APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach	2019-02-04
PMN P180001 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith? TX2? Dissection Endovascular Graft with Pro-Form, Tapered Component	2019-01-18
PMN P180001 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith? TX2? Dissection Endovascular Graft with Pro-Form, Straight Component	2019-01-18
PMN P180001 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith? Dissection Endovascular Stent	2019-01-18
PMA P180001 WILLIAM COOK EUROPE APS	Zenith Dissection Endovascular System	2018-12-31
PMN K161813 | BTR APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Frova Intubating Introducer, Frova Intubating Catheter	2018-12-12
PMA P070016S009 WILLIAM COOK EUROPE APS	ZENITH TX2 TAA ENDVASCULAR GRAFT	2018-10-10
PMN K171513 | DQX APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Lunderquist? Extra Stiff Wire Guide	2018-09-26
PMN K171513 | DQX APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Lunderquist? Extra Stiff DC Wire Guide	2018-09-26
PMN K171513 William Cook Europe ApS	Lunderquist Extra Stiff Wire Guide	2017-12-07
PMN K172584 William Cook Europe ApS	Günther Tulip Vena Cava Filter Set For Femoral Vein Approach, Günther Tulip Vena Cava Filter Set For Femoral And Jugular Vein Approach	2017-11-20
PMN K172557 William Cook Europe ApS	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	2017-11-20
PMN K171712 William Cook Europe ApS	Cook 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 Approach	2017-08-07
PMN K161813 WILLIAM COOK EUROPE APS	Frova Intubating Introducer	2017-05-19
PMN K150964 | KRD APRIL LAVENDER [WILLIAM COOK EUROPE APS]	MReye? Flipper? Detachable Embolization Coil	2016-03-23
PMN K150964 | KRD APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Flipper? Delivery System	2016-03-23
PMN P140016 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component	2015-09-22
PMN P140016 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith Alpha, Thoracic Endovascular Graft, Proximal Component	2015-09-22
PMN P140016 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith Alpha, Thoracic Endovascular Graft, Distal Extension	2015-09-22
PMN P140016 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith Alpha, Thoracic Endovascular Graft, Distal Component	2015-09-22
PMA P070016S010 WILLIAM COOK EUROPE APS	ZENITH TX2 TAA ENDOVASCULAR GRAFT	2015-08-03
PMA P070016S007 WILLIAM COOK EUROPE APS	ZENITH TX2 THORACIC ENDOVASCULAR GRAFT	2013-05-20
PMA P070016S005 WILLIAM COOK EUROPE APS	ZENITH TX2 TAA ENDOVASCULAR GRAFT	2012-11-05
PMN K121629 WILLIAM COOK EUROPE APS	COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR	2012-07-03
PMN K121057 WILLIAM COOK EUROPE APS	COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS	2012-05-04
PMN K112119 WILLIAM COOK EUROPE APS	CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH	2012-03-30
PMA P070016S006 WILLIAM COOK EUROPE APS	ZENITH TX2 TAA ENDOVASCULAR GRAFT	2011-12-06
PMN P100028 | NIN APRIL LAVENDER [WILLIAM COOK EUROPE APS]	FormulaTM 414 RX Renal Ballon-Expandable Stent	2011-04-04
PMA P070016S004 WILLIAM COOK EUROPE APS	ZENITH TX2 TAA ENDOVASCULAR GRAFT	2009-05-21
PMN K090140 WILLIAM COOK EUROPE APS	GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER	2009-04-03
PMA P070016S003 WILLIAM COOK EUROPE APS	ZENITH TX2 TAA ENDOVASCULAR GRAFT	2009-01-27
PMA P070016S001 WILLIAM COOK EUROPE APS	ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM	2008-11-26
PMA P070016S002 WILLIAM COOK EUROPE APS	ZENITH TX2 TAA ENDOVASCULAR GRAFT	2008-11-25
PMN P070016 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith? TX2? TAA Endovascular Graft	2008-06-09
PMN P070016 | MIH APRIL LAVENDER [WILLIAM COOK EUROPE APS]	Zenith? TX2? TAA Endovascular Graft with Pro-FormTM	2008-06-09
PMA P070016 WILLIAM COOK EUROPE APS	ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM	2008-05-21
PMN K073374 WILLIAM COOK EUROPE APS	COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET	2008-03-07
PMN K061815 WILLIAM COOK EUROPE APS	COOK CELECT VENA CAVA FILTER	2007-04-20
PMN K061670 WILLIAM COOK EUROPE APS	LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE	2007-01-19

Similar & Related FDA Registered Companies

• 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/components/specifications/material Expedited Review Granted? No
• 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 Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• 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 Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019031343938	Anvers,Belgium -> Long Beach, California	ROFIN STARCUT LASER	2 UNT