FDA 510(k) Application Details - K142500

Device Classification Name	Cpb Check Valve, Retrograde Flow, In-Line   More FDA Info for this Device
510(K) Number	K142500
Device Name	Cpb Check Valve, Retrograde Flow, In-Line
Applicant	Terumo Cardiovascular Systems Corporation 28 Howe Street Ashland, MA 01721 US Other 510(k) Applications for this Company
Contact	Suzanne Grenier Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	MJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2014
Decision Date	01/29/2015
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