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

    FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01

    K Number: K080621 · Decision Apr 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
    K Number
    K080621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    European Custom Manufacturing BV
    Date Received
    March 5, 2008
    Decision Date
    April 29, 2008
    Product Code
    DSA
    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
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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    Other Clearances by European Custom Manufacturing BV

    K Number Device Name
    K033858 TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE