Medical Device Manufacturer · US , Irvine , CA

Balt USA, LLC - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2018

18

Total

18

Cleared

0

Denied

FDA 510(k) Regulatory Record - Balt USA, LLC Cardiovascular ✕

1 devices

1-1 of 1

Cleared May 30, 2025

Prestige Coil System (Prestige Packing Line Extension)

Cardiovascular · 28d