FDA 510(k) Application Details - K032068

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K032068
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	CARDIOVENTION, INC. 3045 STENDER WAY SANTA CLARA, CA 95054 US Other 510(k) Applications for this Company
Contact	TESSA YAMUT Other 510(k) Applications for this Contact
Regulation Number	870.4240   More FDA Info for this Regulation Number
Classification Product Code	DTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2003
Decision Date	08/22/2003
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