# Arch Catheter, LLC

- Location (FDA's records): Ninety Six, SC
- FDA decisions: 1 (2020–2020): 1 510(k) clearance
- Product codes: MJN (1)
- Predicates its devices cite: 3 (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
- Coaxia, Inc.: 1 (https://510kreport.com/company/coaxia)
- Via Biomedical, Inc.: 1 (https://510kreport.com/company/via-biomedical)
- Qxmedical, LLC: 1 (https://510kreport.com/company/qxmedical)

## Recent decisions
- K192786: Gatekeeper Balloon Catheter (Apr 25, 2020)

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