# William Cook Europe Aps

- Location (FDA's records): Bjaeverskov, DK
- FDA decisions: 20 (2007–2025): 18 510(k) clearances and 2 original PMA approvals
- Product codes: DTK (12), DQX (4), BTR (2), MIH (2)
- 510(k) review time since 2016: median 74 days, against 88 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 18 (15 its own); citations of its devices by later devices: 25 (15 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook, Inc.: 2 (https://510kreport.com/company/cook)
- Sheridan Catheter Corp.: 1 (https://510kreport.com/company/sheridan-catheter)

## Firms that cite its devices most
- Cook, Inc.: 3 (https://510kreport.com/company/cook)
- Neometrics, Inc.: 1 (https://510kreport.com/company/neometrics)
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- Aln Implants Chirurgicaux: 1 (https://510kreport.com/company/aln-implants-chirurgicaux)
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)
- Bio2 Medical, Inc.: 1 (https://510kreport.com/company/bio2-medical)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)

## Its most-cited devices
- K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set (2008), cited by 6
- K090140: Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter (2009), cited by 4
- K061670: Lunderquist Wire Guide; DC Wire Guide (2007), cited by 3
- K220137: Lunderquist Extra Stiff Wire Guide (2022), cited by 2
- K161813: Frova Intubating Introducer (2017), cited by 2
- K121057: Cook Celect and Gunther Tulip Vena Cava Filter Sets (2012), cited by 2

## Recent decisions
- K251596: Lunderquist Extra Stiff Wire Guide (Nov 9, 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) (Jun 11, 2025)
- 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 (Jan 18, 2024)
- K220137: Lunderquist Extra Stiff Wire Guide (Feb 17, 2022)
- 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 (Jul 28, 2021)
- 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 (Jul 28, 2021)
- P180001: Zenith Dissection Endovascular System (Dec 31, 2018)
- K171513: Lunderquist Extra Stiff Wire Guide (Dec 7, 2017)

Source page: https://510kreport.com/company/william-cook-europe