The following data is part of a premarket notification filed by Cardiothoracic Systems, Inc. with the FDA for Heart-lift Balloon Positioner.
| Device ID | K982419 |
| 510k Number | K982419 |
| Device Name: | HEART-LIFT BALLOON POSITIONER |
| Classification | Stabilizer, Heart |
| Applicant | CARDIOTHORACIC SYSTEMS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Contact | Mike Billig |
| Correspondent | Mike Billig CARDIOTHORACIC SYSTEMS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Product Code | MWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1999-01-13 |
| Summary: | summary |