The following data is part of a premarket notification filed by Cardiothoracic Systems, Inc. with the FDA for Cts Midcab Coronary Shunt.
| Device ID | K963503 |
| 510k Number | K963503 |
| Device Name: | CTS MIDCAB CORONARY SHUNT |
| Classification | Clamp, Vascular |
| Applicant | CARDIOTHORACIC SYSTEMS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig CARDIOTHORACIC SYSTEMS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1997-04-03 |
| Summary: | summary |