FDA 510(k) Application Details - K113235

Device Classification Name	Gauge, Pressure, Coronary, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K113235
Device Name	Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Applicant	MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	AMRA RACIC Other 510(k) Applications for this Contact
Regulation Number	870.4310   More FDA Info for this Regulation Number
Classification Product Code	DXS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2011
Decision Date	12/02/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review