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FDA 510(k)

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

K-Number: K240908 · 2025-07-08

ApplicantSpectrum Medical , Ltd.
Decision Date2025-07-08
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-08 under approval number K240908. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is a medical device that received FDA 510(k) clearance on 2025-07-08. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K240908.

When was Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) approved by the FDA?

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) received FDA 510(k) clearance on 2025-07-08, under approval number K240908.

What company makes Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is manufactured by Spectrum Medical , Ltd..

What is the FDA product code for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

The FDA product code for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is DTR.

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Related Devices (Code: DTR)

K162774MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)Medtronic, Inc. K162958MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with BridgeMedtronic, Inc. K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. K201984MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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