The following data is part of a premarket notification filed by Cardio Thoracic Systems with the FDA for Deknatel Gwathmey Vascular Stapling Kit (tenative).
| Device ID | K864146 |
| 510k Number | K864146 |
| Device Name: | DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) |
| Classification | Staple, Implantable |
| Applicant | CARDIO THORACIC SYSTEMS 10600 N. TANTAU AVE. Cupertino, CA 95014 -0739 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig CARDIO THORACIC SYSTEMS 10600 N. TANTAU AVE. Cupertino, CA 95014 -0739 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-22 |
| Decision Date | 1986-11-05 |