FDA 510(k) Application Details - K991783

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K991783
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	CARDIAC ASSIST, INC. 240 ALPHA DR. PITTSBURGH, PA 15238 US Other 510(k) Applications for this Company
Contact	RICHARD G CONFER 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	05/25/1999
Decision Date	11/01/2000
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