FDA 510(k) Application Details - K973011

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K973011
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	THOMAS K JOHNSEN 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	08/13/1997
Decision Date	02/25/1998
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