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FDA 510(k)

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

K-Number: K212688 · 2022-01-10

ApplicantQura S.R.L
Decision Date2022-01-10
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger is a medical device manufactured by Qura S.R.L. It received FDA 510(k) clearance on 2022-01-10 under approval number K212688. 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 PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger?

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger is a medical device that received FDA 510(k) clearance on 2022-01-10. It is manufactured by Qura S.R.L. The 510(k) number is K212688.

When was Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger approved by the FDA?

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger received FDA 510(k) clearance on 2022-01-10, under approval number K212688.

What company makes Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger?

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger is manufactured by Qura S.R.L.

What is the FDA product code for Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger?

The FDA product code for Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger is DTR.

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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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