510(k) K142500

One Way Soft Valve by Terumo Cardiovascular Systems Corporation — Product Code MJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2015
Date Received
September 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cpb Check Valve, Retrograde Flow, In-Line
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type