William Cook Europe ApS
BJAEVERSKOV Sjaelland, DK
WILLIAM COOK EUROPE APS appears in FDA device records in BJAEVERSKOV Sjaelland, DK. FDA records list 18 510(k) clearances between and , 28 PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for William Cook Europe ApS between 2007 and 2025. The busiest year on record is 2017, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2012 | 3 |
| 2017 | 5 |
| 2021 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251596 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | |
| 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 | |
| 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 | |
| K220137 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | |
| K211875 | 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 | DTK | Substantially Equivalent | |
| K211874 | 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 | DTK | Substantially Equivalent | |
| K171513 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | DTK | Substantially Equivalent | |
| K172557 | 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 | DTK | Substantially Equivalent | |
| K171712 | 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 | DTK | Substantially Equivalent | |
| K161813 | Frova Intubating Introducer | BTR | Substantially Equivalent | |
| K121629 | COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR | DTK | Substantially Equivalent | |
| K121057 | COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS | DTK | Substantially Equivalent | |
| K112119 | CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH | DTK | Substantially Equivalent | |
| K090140 | GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER | DTK | Substantially Equivalent | |
| K073374 | COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET | DTK | Substantially Equivalent | |
| K061815 | COOK CELECT VENA CAVA FILTER | DTK | Substantially Equivalent | |
| K061670 | LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE | DQX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002808486 | 3002808486 | WILLIAM COOK EUROPE APS | SANDET 6, BJAEVERSKOV Sjaelland DK-4632 DK | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain