FDA 510(k) Application Details - K040184

Device Classification Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line   More FDA Info for this Device
510(K) Number	K040184
Device Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
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	870.4260   More FDA Info for this Regulation Number
Classification Product Code	DTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2004
Decision Date	02/26/2004
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