William Cook Europe Aps: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “William Cook Europe Aps” (first 2007, latest 2025), plus 2 PMA decisions, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 78 days. Since 2017 the median was 63 days, against 143 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Cook Medical, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 29 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 5 | 88 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 41 |
| 2022 | 1 | 30 |
| 2023 | 0 | — |
| 2024 | 1 | 63 |
| 2025 | 2 | 96 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name William Cook Europe Aps took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTK | Filter, Intravascular, Cardiovascular | 12 | 12 |
| DQX | Wire, Guide, Catheter | 4 | 4 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 2 | 0 |
Review panels
- Cardiovascular (18)
- Anesthesiology (2)
Most recent William Cook Europe Aps 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251596 | Lunderquist Extra Stiff Wire Guide | DQX | 2025-11-09 | 166 |
| 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 | 2025-06-11 | 27 |
| 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 | 2024-01-18 | 63 |
| K220137 | Lunderquist Extra Stiff Wire Guide | DQX | 2022-02-17 | 30 |
| 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 | 2021-07-28 | 41 |
| 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 | 2021-07-28 | 41 |
| K171513 | Lunderquist Extra Stiff Wire Guide | DQX | 2017-12-07 | 197 |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | DTK | 2017-11-20 | 84 |
| 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 | 2017-11-20 | 88 |
| 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 | 2017-08-07 | 59 |
8 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180001 | PMA | Zenith Dissection Endovascular System | 2018-12-31 |
| P070016 | PMA | ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM | 2008-05-21 |
Recalls
openFDA lists no recalls under a recalling firm named William Cook Europe Aps.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- William A. Cook Australia Pty. , Ltd. (14 510(k)s)
- William Harvey Life Products Corp. (3 510(k)s)
- William C. Nealon (1 510(k)s)
- William Dixon Co. (1 510(k)s)
- William E. Mckay (1 510(k)s)
- William F. Trinkaus (1 510(k)s)
- William F. Whittingham (1 510(k)s)
- William Feinstein & Associates, Inc. (1 510(k)s)
- William J. Day (1 510(k)s)
- William J. Forni, D.D.S. (1 510(k)s)
- William K. Hagan (1 510(k)s)
- William Skidmore & Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under William Cook Europe Aps?
FDA lists 18 510(k) clearances under the applicant name “William Cook Europe Aps” (first 2007, latest 2025), plus 2 PMA decisions, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by William Cook Europe Aps?
The median time from FDA receipt to decision across 510(k)s cleared under the name William Cook Europe Aps is 78 days. Since 2017: 63 days, versus 143 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under William Cook Europe Aps?
The most frequent FDA product codes under this applicant name are DTK (Filter, Intravascular, Cardiovascular, 12); DQX (Wire, Guide, Catheter, 4); BTR (Tube, Tracheal (W/Wo Connector), 2).
Next steps
- See all 18 William Cook Europe Aps clearances with predicates and recalls
- Run predicate analysis for product code DTK, William Cook Europe Aps's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.