BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LifeSPARC System

    K Number: K211830 · Decision Nov 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    21
    Review Days
    519

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    Basic Information

    Device Name
    LifeSPARC System
    K Number
    K211830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiacassist, Inc.
    Date Received
    June 14, 2021
    Decision Date
    November 15, 2022
    Product Code
    QNR
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

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