Cardiothoracic Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K010117 | GUIDANT AXIUS CORONARY SHUNT | April 4, 2001 |
| K983270 | VOYAGER QUAD CANNULA | July 28, 1999 |
| K982419 | HEART-LIFT BALLOON POSITIONER | January 13, 1999 |
| K983135 | BLOWER/MISTER | November 13, 1998 |
| K963965 | CTS MIDCAB STITCHER | March 17, 1998 |
| K970638 | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT | October 30, 1997 |
| K963503 | CTS MIDCAB CORONARY SHUNT | April 3, 1997 |
| K963930 | CTS MIDCAB/SVH BIPOLAR SCISSORS | January 16, 1997 |