Medical Device Manufacturer · US , Norwell , MA

Vortex Medical, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2009

Recent clearances: ANGIOVAC CANNULA, VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT, VORTEX CANNULA

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Vortex Medical, Inc. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Mar 05, 2014

ANGIOVAC CANNULA

Cardiovascular · 113d

Cleared Aug 28, 2009

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT

Cardiovascular · 15d

Cleared Jul 02, 2009

Cardiovascular · 59d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 19, 2026