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510(k) K240908

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) by Spectrum Medical , Ltd. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2025
Date Received
April 2, 2024
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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Other clearances for product code DTR

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  • K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (April 13, 2023)
  • K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat (May 6, 2022)
  • K212688 — Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exc (January 10, 2022)
  • K201984 — MPS 3 ND Myocardial Protection System (November 20, 2020)
  • K200438 — MPS 3 Myocardial Protection System (June 19, 2020)
  • K173716 — MPS2 Myocardial Protection System Console (October 1, 2018)
  • K162774 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOther (February 10, 2017)