The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Tracer O-t-w Mapping Device.
| Device ID | K972803 |
| 510k Number | K972803 |
| Device Name: | TRACER O-T-W MAPPING DEVICE |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
| Contact | Shelley Trimm |
| Correspondent | Shelley Trimm CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1999-05-11 |
| Summary: | summary |