Cardiothoracic Systems, Inc. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardiothoracic Systems, Inc. Cardiovascular ✕
5 devices
Cleared
Apr 04, 2001
GUIDANT AXIUS CORONARY SHUNT
Cardiovascular
78d
Cleared
Jul 28, 1999
VOYAGER QUAD CANNULA
Cardiovascular
314d
Cleared
Jan 13, 1999
HEART-LIFT BALLOON POSITIONER
Cardiovascular
184d
Cleared
Oct 30, 1997
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
Cardiovascular
252d
Cleared
Apr 03, 1997
CTS MIDCAB CORONARY SHUNT
Cardiovascular
212d