FDA 510(k) Application Details - K011835

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K011835
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY ARVADA, CO 80004 US Other 510(k) Applications for this Company
Contact	LYNNE LEONARD Other 510(k) Applications for this Contact
Regulation Number	870.4360   More FDA Info for this Regulation Number
Classification Product Code	KFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2001
Decision Date	02/12/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review