FDA applicant
Cagent Vascular, LLC
FDA records 5 decisions for Cagent Vascular, LLC (Wayne, PA) from 2017 to 2022: 5 510(k) clearances. All are in product code PNO (Catheter, Percutaneous, Cutting/Scoring). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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 Cagent Vascular, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Cagent Vascular, LLC’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