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510(k) K223879

Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) by Quara S.R.L. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2023
Date Received
December 27, 2022
Clearance Type
Special
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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