FDA applicant
William Cook Europe Aps
FDA records 20 decisions for William Cook Europe Aps (Bjaeverskov, DK) from 2007 to 2025: 18 510(k) clearances and 2 original PMA approvals. Most are in product codes DTK (Filter, Intravascular, Cardiovascular) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 15 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided William Cook Europe Aps’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2022
Class I Class II/III not classified
Planning a device like William Cook Europe Aps’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “William”
FDA records each applicant name separately; these may or may not be the same firm.