Medical Device Manufacturer · US , Plymouth , MN

Cultiv8 1, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2026

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cultiv8 1, LLC Cardiovascular ✕

1 devices

1-1 of 1

Cleared Jan 22, 2026

Genie MAX Large Bore Introducer Sheath

Cardiovascular · 63d