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

    LifeSPARC System

    K Number: K232132 · Decision Aug 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    21
    Review Days
    16

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    Basic Information

    Device Name
    LifeSPARC System
    K Number
    K232132
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiacassist, Inc.
    Date Received
    July 18, 2023
    Decision Date
    August 3, 2023
    Product Code
    KFM
    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
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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    Other Clearances by Cardiacassist, Inc.

    K Number Device Name
    K233736 LifeSPARC System
    K232480 ProtekDuo Veno-Venous Cannula Sets
    K211830 LifeSPARC System
    K202751 TandemHeart Pump and Escort Controller
    K183623 LifeSPARC Pump, LifeSPARC Controller
    K181150 ProtekDuo Mini Veno-Venous Cannula Set
    K162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
    K162214 Protek Solo 24 Fr Venous Cannula Set
    K160257 PROTEK Duo 31 Fr. Veno-Venous Cannula Set
    K153295 TandemLung Oxygenator
    Search all 21 clearances from Cardiacassist, Inc. →