FDA 510(k) Application Details - K021830

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K021830
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY ARVADA, CO 80004 US Other 510(k) Applications for this Company
Contact	SHAWN RIEDEL 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	06/04/2002
Decision Date	07/02/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review