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FDA 510(k)

Quantum Perfusion Hybrid System

K-Number: K241206 · 2024-07-18

ApplicantSpectrum Medical S.R.L.
Decision Date2024-07-18
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Perfusion Hybrid System is a medical device manufactured by Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2024-07-18 under approval number K241206. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Perfusion Hybrid System?

Quantum Perfusion Hybrid System is a medical device that received FDA 510(k) clearance on 2024-07-18. It is manufactured by Spectrum Medical S.R.L.. The 510(k) number is K241206.

When was Quantum Perfusion Hybrid System approved by the FDA?

Quantum Perfusion Hybrid System received FDA 510(k) clearance on 2024-07-18, under approval number K241206.

What company makes Quantum Perfusion Hybrid System?

Quantum Perfusion Hybrid System is manufactured by Spectrum Medical S.R.L..

What is the FDA product code for Quantum Perfusion Hybrid System?

The FDA product code for Quantum Perfusion Hybrid System is DTN.

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Other Devices by Spectrum Medical S.R.L.

K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

Related Devices (Code: DTN)

K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L. K223361BMR 1900 PHISIOSorin Group Italia S.R.L. K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac Surgery K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia 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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