The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Cardima Pathfinder 1.5f Mapping Microcatheter.
| Device ID | K971975 |
| 510k Number | K971975 |
| Device Name: | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CARDIMA, INC. 47266 BENICIA ST. P.O. BOX 14172 Fremont, CA 94539 -1372 |
| Contact | Jack P Douglas |
| Correspondent | Jack P Douglas CARDIMA, INC. 47266 BENICIA ST. P.O. BOX 14172 Fremont, CA 94539 -1372 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1998-07-01 |
| Summary: | summary |