Medical Device Manufacturer · US , San Juan Capistrano , CA

South53, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2025

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - South53, LLC Cardiovascular ✕

1 devices

1-1 of 1

Cleared Sep 29, 2025

Primero Safe Access System

Cardiovascular · 56d

Data Source

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

Last updated: Apr 27, 2026