Medical Device Manufacturer · US , Cardiff By The Sea , CA

Atraverse Medical, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Atraverse Medical, Inc. Cardiovascular ✕

1 devices

1-1 of 1

Cleared Aug 27, 2025

HOTWIRE RF GUIDEWIRE (901XXX)

Cardiovascular · 26d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026