Medical Device Manufacturer · US , Ballerup Denmark

Polystan C/O Vitalcor, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1984

Recent clearances: POLYSTAN HEART-LUNG MACHINE SYSTEM, POLYSTAN HEATER-COOLER UNIT, SAFE-1

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Polystan C/O Vitalcor, Inc. Toxicology ✕

1 devices

1-1 of 1

Cleared Mar 28, 1990

POLYSTAN HEART-LUNG MACHINE SYSTEM

Toxicology · 247d