Medical Device Manufacturer · US , Cupertino , CA

Cardiothoracic Systems, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1997

Recent clearances: GUIDANT AXIUS CORONARY SHUNT, VOYAGER QUAD CANNULA, HEART-LIFT BALLOON POSITIONER

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiothoracic Systems, Inc. General & Plastic Surgery ✕

2 devices

1-2 of 2

Cleared Mar 17, 1998

CTS MIDCAB STITCHER

General & Plastic Surgery · 531d

Cleared Jan 16, 1997

CTS MIDCAB/SVH BIPOLAR SCISSORS

General & Plastic Surgery · 107d