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510(k) K190650

Revolution Centrifugal Blood Pump by Sorin Group Italia S.R.L. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2019
Date Received
March 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

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