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510(k) Data Aggregation

    K Number
    K250326
    Device Name
    Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
    Manufacturer
    Spectrum Medical S.r.l.
    Date Cleared
    2025-06-24

    (139 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spectrum Medical S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. Device is intended for adult patients.
    Device Description
    The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours. The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.
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    K Number
    K241206
    Device Name
    Quantum Perfusion Hybrid System
    Manufacturer
    Spectrum Medical S.r.l.
    Date Cleared
    2024-07-18

    (79 days)

    Product Code
    DTN, PAN
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spectrum Medical S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.
    Device Description
    The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.
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    K Number
    K241248
    Device Name
    Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
    Manufacturer
    Spectrum Medical s.r.l.
    Date Cleared
    2024-05-31

    (28 days)

    Product Code
    DWF, PAN
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spectrum Medical s.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
    Device Description
    Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal. Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter. Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood. Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholine-based biocompatible material.
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