FDA 510(k) Application Details - K100646

Device Classification Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line   More FDA Info for this Device
510(K) Number	K100646
Device Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant	MEDTRONIC INC. 7611 NORTHLAND DRIVE MINNEAPOLIS, MN 55428 US Other 510(k) Applications for this Company
Contact	JEFFREY L KOLL 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	03/05/2010
Decision Date	12/16/2010
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