FDA 510(k) Application Details - K970496

Device Classification Name	Surgical Device, For Ablation Of Cardiac Tissue   More FDA Info for this Device
510(K) Number	K970496
Device Name	Surgical Device, For Ablation Of Cardiac Tissue
Applicant	HEARTPORT, INC. 200 CHESAPEAKE DR. REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	MARIANNE C DRENNAN Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	OCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/1997
Decision Date	05/09/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review