FDA 510(k)

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

N.º K: K241248 · 2024-05-31

Fecha de decisión2024-05-31

Código de productoDWF

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K241248.

When did Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) receive FDA 510(k) clearance?

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

Who is the listed applicant for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

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

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.

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Otros registros que enlistan a Spectrum Medical S.R.L. como solicitante

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);K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)K241206Quantum Perfusion Hybrid System

Dispositivos relacionados (Código: DWF)

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

Fuente oficial

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