FDA 510(k) Application Details - K001822

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K001822
Device Name	Reservoir, Blood, Cardiopulmonary Bypass
Applicant	CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. OYSTER BAY, NY 11771 US Other 510(k) Applications for this Company
Contact	YEHUDA TAMARI Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	DTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2000
Decision Date	07/07/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review