FDA applicant
Angiotech
FDA records 7 decisions for Angiotech (Reading, PA) from 2007 to 2015: 6 510(k) clearances and 1 De Novo grant. Most are in product codes GAW (Suture, Nonabsorbable, Synthetic, Polypropylene) and NEW (Suture, Surgical, Absorbable, Polydioxanone). Its devices cite 10 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Angiotech’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Angiotech’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 “Angiotech”
FDA records each applicant name separately; these may or may not be the same firm.