The following data is part of a premarket notification filed by Cardiothoracic Systems, Inc. with the FDA for Cts Midcab Stitcher.
| Device ID | K963965 |
| 510k Number | K963965 |
| Device Name: | CTS MIDCAB STITCHER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1998-03-17 |
| Summary: | summary |