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

    WECK CARDIAC PACING WIRES

    K Number: K011660 · Decision Aug 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    127
    Applicant Total
    6
    Review Days
    84

    Basic Information

    Device Name
    WECK CARDIAC PACING WIRES
    K Number
    K011660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WECK CLOSURE SYSTEMS
    Date Received
    May 29, 2001
    Decision Date
    August 21, 2001
    Product Code
    LDF
    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
    LDF Electrode, Pacemaker, Temporary

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    Other Clearances by WECK CLOSURE SYSTEMS

    K Number Device Name
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    K993157 HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
    K982944 HEM-O-LOCK, MODEL 523935
    K982941 HEM-O-LOK MODEL NUMBERS 523900, 523970
    K982313 HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS