Company ยท US
Cardiothoracic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2001. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2001 | K010117 | GUIDANT AXIUS CORONARY SHUNT Cardiothoracic Systems, Inc. | DXC |
| Jul 28, 1999 | K983270 | VOYAGER QUAD CANNULA Cardiothoracic Systems, Inc. | DWF |
| Jan 13, 1999 | K982419 | HEART-LIFT BALLOON POSITIONER Cardiothoracic Systems, Inc. | MWS |
| Nov 13, 1998 | K983135 | BLOWER/MISTER Cardiothoracic Systems, Inc. | FQH |
| Mar 17, 1998 | K963965 | CTS MIDCAB STITCHER Cardiothoracic Systems, Inc. | GEI |
| Oct 30, 1997 | K970638 | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT Cardiothoracic Systems, Inc. | DXC |
| Apr 3, 1997 | K963503 | CTS MIDCAB CORONARY SHUNT Cardiothoracic Systems, Inc. | DXC |
| Jan 16, 1997 | K963930 | CTS MIDCAB/SVH BIPOLAR SCISSORS Cardiothoracic Systems, Inc. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||