FDA 510(k) Application Details - K955802

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K955802
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	CARDIMA, INC. 47266 BENICIA ST. P.O. BOX 14172 FREMONT, CA 94539-1372 US Other 510(k) Applications for this Company
Contact	GABRIEL VEGH Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1995
Decision Date	01/29/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review