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510(k) K220110

Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger by Qura S.R.L — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2022
Date Received
January 13, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type

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