Medical Device Manufacturer · US , Irvine , CA

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

18 submissions · 18 cleared · Since 2018

Recent clearances: Next Generation 088 Catheter, Optima Coil System (OptiOne Coil System), Carrier XL Delivery Catheter

18
Total
18
Cleared
0
Denied

Balt USA, LLC has 18 FDA 510(k) cleared neurology devices. Based in Irvine, US.

Latest FDA clearance: Apr 2026. Active since 2018.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

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

18 devices
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