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

    BIOTRONIK DY-UNIPOLAR

    K Number: K841451 · Decision Feb 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    41
    Review Days
    304

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    Basic Information

    Device Name
    BIOTRONIK DY-UNIPOLAR
    K Number
    K841451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biotronik Sales, Inc.
    Date Received
    April 9, 1984
    Decision Date
    February 7, 1985
    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 Biotronik Sales, Inc.

    K Number Device Name
    K875199 NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
    K853194 ERA-20
    K860036 EDP-20 PACEMAKER
    K863879 NEOS-M VS-1 PULSE GENERATOR
    K863878 TRIOS-M VS-1 PULSE GENERATOR
    K863480 BIOTRONIK PERMANENT PACEMAKER ELECTRODE
    K860921 NEOS VS-1, PULSE GENERATOR
    K860922 MIKROS, MIKROS VS-1, PULSE GENERATOR
    K853567 DJP UNIPOLAR
    K853566 DJ UNIPOLAR
    Search all 41 clearances from Biotronik Sales, Inc. →