The following data is part of a premarket notification filed by Cardio Thoracic Systems with the FDA for Vacuum Assist Stabilizer.
| Device ID | K992833 |
| 510k Number | K992833 |
| Device Name: | VACUUM ASSIST STABILIZER |
| Classification | Stabilizer, Heart |
| Applicant | CARDIO THORACIC SYSTEMS 10600 N. TANTAU AVE. Cupertino, CA 95014 -0739 |
| Contact | Michael Billig |
| Correspondent | Michael Billig CARDIO THORACIC SYSTEMS 10600 N. TANTAU AVE. Cupertino, CA 95014 -0739 |
| Product Code | MWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 1999-11-10 |
| Summary: | summary |