Medical Device Manufacturer · US , Irvine , CA

Sorin Biomedical, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1993

Recent clearances: MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE, CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE, DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sorin Biomedical, Inc. Anesthesiology ✕

2 devices

1-2 of 2

Cleared Feb 20, 1998

CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE

Anesthesiology · 520d

Cleared Feb 20, 1998

DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS

Anesthesiology · 520d