# Atraverse Medical

- Location (FDA's records): Cardiff By The Sea, CA
- FDA decisions: 4 (2024–2026): 4 510(k) clearances
- Names in FDA's records: Atraverse Medical (2); Atraverse Medical, Inc. (2)
- Product codes: DXF (3), GEI (1)
- 510(k) review time since 2016: median 30 days, against 83 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 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
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- Cross Vascular, Inc.: 1 (https://510kreport.com/company/cross-vascular)

## Its most-cited devices
- K240900: HOTWIRE™ RF Guidewire (2024), cited by 1
- K252419: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) (2025), cited by 1

## Recent decisions
- K260292: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) (Feb 27, 2026)
- K252419: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) (Aug 27, 2025)
- K252083: HOTWIRE™ System RF Generator and Footswitch (optional accessory) (Aug 12, 2025)
- K240900: HOTWIRE™ RF Guidewire (May 1, 2024)

Source page: https://510kreport.com/company/atraverse-medical