FDA 510(k) Application Details - K974175

Device Classification Name	Device, Biopsy, Endomyocardial   More FDA Info for this Device
510(K) Number	K974175
Device Name	Device, Biopsy, Endomyocardial
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	870.4075   More FDA Info for this Regulation Number
Classification Product Code	DWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/1997
Decision Date	12/16/1997
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