The following data is part of a premarket notification filed by Guidant Corporation, Cardiac Surgery with the FDA for Syncrus Internal Cardioversion System.
| Device ID | K020701 |
| 510k Number | K020701 |
| Device Name: | SYNCRUS INTERNAL CARDIOVERSION SYSTEM |
| Classification | Electrode, Pacing And Cardioversion, Temporary, Epicardial |
| Applicant | GUIDANT CORPORATION, CARDIAC SURGERY 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Debbie Cogan |
| Correspondent | Debbie Cogan GUIDANT CORPORATION, CARDIAC SURGERY 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | NHW |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-04 |
| Decision Date | 2002-05-24 |
| Summary: | summary |