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 |