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510(k) K192850

Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 by Qura S.R.L — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2020
Date Received
October 3, 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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