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

    MISCELLANEOUS PACING LEAD

    K Number: K925168 · Decision May 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    31
    Review Days
    567

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    Basic Information

    Device Name
    MISCELLANEOUS PACING LEAD
    K Number
    K925168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oscor Medical Corp.
    Date Received
    October 13, 1992
    Decision Date
    May 3, 1994
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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    Other Clearances by Oscor Medical Corp.

    K Number Device Name
    K964107 OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
    K923621 EXTERNAL DEMAND PACEMAKER
    K912867 OSCOR MEDICAL CORP PERMANENT PACING LEAD
    K915007 PERMANENT PACING LEADS, MODIFICATION
    K915008 PERMANENT PACING PAD, MODIFICATION
    K913204 MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
    K913158 MODIFIED OSCOR PY PACING LEADS/MODIFICATION
    K913202 IMPLANT PACING LEAD, TINED #3262, MODIFICATION
    K913203 IMPLANT PACING LEAD TINED #3390, MODIFICATION
    K913201 PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
    Search all 31 clearances from Oscor Medical Corp. →