The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Pathfinder 3mm Mapping Microcatheter (01-082001).
Device ID | K970853 |
510k Number | K970853 |
Device Name: | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) |
Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
Applicant | CARDIMA, INC. 47266 BENICIA ST. Fremont, CA 94538 -1372 |
Contact | Jack P Douglas, Ph.d. |
Correspondent | Jack P Douglas, Ph.d. 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 | 1997-03-07 |
Decision Date | 1997-11-04 |
Summary: | summary |