# Tractus Vascular, LLC

- Location (FDA's records): Eatontown, NJ
- FDA decisions: 3 (2018–2023): 3 510(k) clearances
- Product codes: DQY (2), PDU (1)
- 510(k) review time since 2016: median 250 days, against 111 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 0 (0 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
- Spectranetics Corp.: 2 (https://510kreport.com/company/spectranetics)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)
- Thermopeutix, Inc.: 2 (https://510kreport.com/company/thermopeutix)
- Bridgepoint Medical: 1 (https://510kreport.com/company/bridgepoint-medical)

## Recent decisions
- K221163: Tunnel Crossing Catheter (Jan 19, 2023)
- K183305: Crossing Support Catheter (Aug 5, 2019)
- K180889: Tractus Crossing Support Catheter (Dec 7, 2018)

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