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FDA 510(k)

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

K-Number: K241248 · 2024-05-31

ApplicantSpectrum Medical S.R.L.
Decision Date2024-05-31
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is a medical device manufactured by Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2024-05-31 under approval number K241248. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is a medical device that received FDA 510(k) clearance on 2024-05-31. It is manufactured by Spectrum Medical S.R.L.. The 510(k) number is K241248.

When was Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) approved by the FDA?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) received FDA 510(k) clearance on 2024-05-31, under approval number K241248.

What company makes Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is manufactured by Spectrum Medical S.R.L..

What is the FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

The FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is DWF.

Related Clinical Trials

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Other Devices by Spectrum Medical S.R.L.

K241206Quantum Perfusion Hybrid System 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: DWF)

K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc. K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. K153598Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. K171979Tubing PackMedtronic, Inc. K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 FrSurge Cardiovascular K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin 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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