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510(k) K201320

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor by Qura S.R.L — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2021
Date Received
May 18, 2020
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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