The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Cardima, Inc. Forerunner.
| Device ID | K951603 |
| 510k Number | K951603 |
| Device Name: | CARDIMA, INC. FORERUNNER |
| Classification | Catheter, Percutaneous |
| Applicant | CARDIMA, INC. 47266 BENICIA ST. P.O. BOX 14172 Fremont, CA 94539 -1372 |
| Contact | J. D Stevens |
| Correspondent | J. D Stevens CARDIMA, INC. 47266 BENICIA ST. P.O. BOX 14172 Fremont, CA 94539 -1372 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-10-05 |