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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 the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-08 under 510(k) 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. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K240908.

When did Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) receive FDA 510(k) clearance?

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

Who is the listed applicant for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

The FDA 510(k) record lists Spectrum Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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)

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K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.LK212688Quantum PureFlow Standard Heat Exchanger, 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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