FDA 510(k) Application Details - K031323

Device Classification Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line   More FDA Info for this Device
510(K) Number	K031323
Device Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant	CONVERGENZA AG 3625 WOODLAKE DR. BONITA SPRINGS, FL 34134 US Other 510(k) Applications for this Company
Contact	CHRISTIE DEWITT 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	04/25/2003
Decision Date	08/01/2003
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