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 |