Data / Medical devices / Denmark / William Cook Europe Aps
William Cook Europe Aps: FDA-registered device maker in BJAEVERSKOV Sjaelland, Denmark, 6 510(k) clearances and 2 PMA approvals
William Cook Europe Aps is registered with the FDA (registration 3002808486) in BJAEVERSKOV Sjaelland, Denmark. It lists 5 device types. The FDA files 6 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 9, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3002808486
- Address
- Sandet 6, BJAEVERSKOV Sjaelland, Denmark, DK-4632
- Owner or operator
- WILLIAM COOK EUROPE APS (9053266)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 22, 2015
- Registered through
- 2027
- Brand names listed
- Celect Platinum® Vena Cava Filter Set for Femoral Vein Approach, Celect Platinum® Vena Cava Filter Set for Femoral and Jugular Vein Approach, Celect Platinum® Vena Cava Filter Set for Jugular Vein Approach, Flipper® Delivery System, Frova Intubating Introducer, Frova Intubating Introducer, Frova Intubating Catheter, Gunther Tulip® Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Filter, Intravascular, Cardiovascular | DTK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2025 | K251596 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| June 11, 2025 | K251499 | 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) | BTR | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| January 18, 2024 | K233680 | 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 | DTK | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| February 17, 2022 | K220137 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| May 19, 2017 | K161813 | Frova Intubating Introducer | BTR | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| December 18, 2015 | K150964 | MReye Flipper Detachable Embolization Coil and Delivery System | KRD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 31, 2018 | P180001 | Zenith Dissection Endovascular System | MIH | 17 | August 4, 2026 | accessdata.fda.gov |
| September 15, 2015 | P140016 | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT | MIH | 18 | August 4, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Guide, Catheter
- All makers of Filter, Intravascular, Cardiovascular
- All makers of System, Endovascular Graft, Aortic Aneurysm Treatment
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Device, Vascular, For Promoting Embolization
Updated August 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.