# Catheter, LLC

- Location (FDA's records): Winsted, CT
- FDA decisions: 1 (2003–2003): 1 510(k) clearance
- Product codes: EZD (1)
- Predicates its devices cite: 1 (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
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)

## Recent decisions
- K030538: American Catheter, Model W3 (Mar 10, 2003)

Source page: https://510kreport.com/company/catheter