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510(k) K150536

Terumo Circuit Tubing by Terumo Cardiovascular Systems Corporation — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2015
Date Received
March 3, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

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