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William Cook Europe ApS

US

Last updated May 24, 2026

What William Cook Europe ApS makes

William Cook Europe ApS manufactures synthetic vascular grafts for vascular reconstruction, as well as single-use guidewires designed for cardiac and peripheral vascular procedures. Their portfolio includes non-neurovascular embolization coils and vena cava filters, both temporary and permanent, alongside bare-metal aortic stents for vascular interventions. The company also produces endotracheal tube introducers for single-use medical applications and specialized tools like embolization implant inserters.

The company’s devices are classified under FDA’s Class II and Class III categories, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, where regulatory compliance follows FDA requirements for medical devices. The company is based in the US, adhering to applicable domestic and international regulatory standards for their respective device classes.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
+1(812)330-5494
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
305302119

Catalogue (442)

Page 9 of 9
DeviceModel / ReferenceRegistriesClassStatus
Zenith Alpha G35502
FDA UDI
Class IIIUnknown
Zenith Alpha G60116
FDA UDI
Class IIIActive
Zenith TX2 Pro-Form G53481
FDA UDI
Class IIIUnknown
Zenith Alpha G35371
FDA UDI
Class IIIActive
Zenith Alpha G35362
FDA UDI
Class IIIActive
Zenith TX2 Pro-Form G53464
FDA UDI
Class IIIUnknown
Zenith TX2 Pro-Form G53424
FDA UDI
Class IIIUnknown
Zenith TX2 Pro-Form G53441
FDA UDI
Class IIIUnknown
Zenith Alpha G35342
FDA UDI
Class IIIActive
Zenith TX2 Pro-Form G53469
FDA UDI
Class IIIUnknown
Zenith Alpha G35364
FDA UDI
Class IIIActive
Formula G18526
FDA UDI
Class IIIUnknown
Zenith Alpha G38178
FDA UDI
Class IIIActive
Zenith TX2 Pro-Form G24140
FDA UDI
Class IIIUnknown
Zenith Alpha G60189
FDA UDI
Class IIIActive
Zenith TX2 Pro-Form G53423
FDA UDI
Class IIIUnknown
Zenith TX2 Pro-Form G24139
FDA UDI
Class IIIUnknown
Zenith TX2 Pro-Form G53447
FDA UDI
Class IIIUnknown
Zenith TX2 Pro-Form G53428
FDA UDI
Class IIIUnknown
Zenith Alpha G38024
FDA UDI
Class IIIActive
Zenith TX2 Pro-Form G53436
FDA UDI
Class IIIUnknown
Zenith Alpha G59958
FDA UDI
Class IIIActive
Cook Celect Vena Cava Filter K061815
FDA 510(k)
Class IIActive
Cunther Tulip(r) Vena Cava Filter Set For Femoral Approach, Cook Celect(r) Vena Cava Filter For Femoral Approach K112119
FDA 510(k)
Class IIActive
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
FDA 510(k)
Class IIActive
Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter K090140
FDA 510(k)
Class IIActive
Lunderquist Extra Stiff Wire Guide K220137
FDA 510(k)
Class IIActive
Lunderquist Wire Guide; Dc Wire Guide K061670
FDA 510(k)
Class IIActive
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
FDA 510(k)
Class IIActive
Cook Celect Platinum Vena Cava Filter Set For Femoral Approach Cook Celect Platium Vena Cava Filter Set For Jugular Appr K121629
FDA 510(k)
Class IIActive
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
FDA 510(k)
Class IIActive
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
FDA 510(k)
Class IIActive
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 K171712
FDA 510(k)
Class IIActive
Frova Intubating Introducer K161813
FDA 510(k)
Class IIActive
Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set K073374
FDA 510(k)
Class IIActive
Lunderquist Extra Stiff Wire Guide K171513
FDA 510(k)
Class IIActive
Lunderquist Extra Stiff Wire Guide K251596
FDA 510(k)
Class IIActive
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach K172584
FDA 510(k)
Class IIActive
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
FDA 510(k)
Class IIActive
Cook Celect And Gunther Tulip Vena Cava Filter Sets K121057
FDA 510(k)
Class IIActive
Zenith Dissection Endovascular System P180001
FDA PMA
Class IIIActive
Zenith Tx2 Thoracic Taa Endovascular Graft With The H&Lb One-Shot Introduction System P070016
FDA PMA
Class IIIActive

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • William Cook Europe Aps BJAEVERSKOV Sjalland · DK FEI 3002808486