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510(k) K252541

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W by Spectrum Medical S.R.L. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
August 12, 2025
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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