FDA 510(k) Application Details - K170583

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K170583
Device Name	Reservoir, Blood, Cardiopulmonary Bypass
Applicant	Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 US Other 510(k) Applications for this Company
Contact	Gayatri Ghadge 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	02/28/2017
Decision Date	03/17/2017
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