Medical Device Manufacturer · US , San Juan Capistrano , CA

Avenu Medical - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2019

Recent clearances: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Avenu Medical Cardiovascular ✕

1 devices

1-1 of 1

Cleared CT Aug 09, 2019

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys...

Cardiovascular · 105d

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 04, 2026