FDA applicant
Vascutek, Ltd.
FDA records 27 decisions for Vascutek, Ltd. (Renfrewshire, Glasgow, GB) from 1991 to 2025: 26 510(k) clearances and 1 original PMA approval. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 269 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 13 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vascutek, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Vascutek, Ltd.’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) Report