# Cagent Vascular, LLC

- Location (FDA's records): Wayne, PA
- FDA decisions: 5 (2017–2022): 5 510(k) clearances
- Product codes: PNO (5)
- 510(k) review time since 2016: median 74 days, against 94 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Angioscore, Inc.: 2 (https://510kreport.com/company/angioscore)

## Its most-cited devices
- K163380: Serranator Alto PTA Serration Balloon Catheter (2017), cited by 1
- K193181: Serranator PTA Serration Balloon Catheter (2020), cited by 1
- K213728: Serranator PTA Serration Balloon Catheter (2021), cited by 1

## Recent decisions
- K220704: Serranator PTA Serration Balloon Catheter (May 4, 2022)
- K213728: Serranator PTA Serration Balloon Catheter (Dec 15, 2021)
- K203437: Serranator PTA Serration Balloon Catheter (Dec 22, 2020)
- K193181: Serranator PTA Serration Balloon Catheter (Apr 15, 2020)
- K163380: Serranator Alto PTA Serration Balloon Catheter (Feb 13, 2017)

Source page: https://510kreport.com/company/cagent-vascular