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

    LEAD TERMINAL PIN CAPS, VARIOUS MODELS

    K Number: K911142 · Decision Aug 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    18
    Review Days
    148

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    Basic Information

    Device Name
    LEAD TERMINAL PIN CAPS, VARIOUS MODELS
    K Number
    K911142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biotronik, GmbH & Co.
    Date Received
    March 14, 1991
    Decision Date
    August 9, 1991
    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, GmbH & Co.

    K Number Device Name
    K000763 PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
    K923406 BIOSCOPE
    K923026 PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
    K922742 HPM 40 HEART PACEMAKER MONITOR
    K914109 PIKOS 01 & PIKOS E 01
    K910609 PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
    K910608 PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
    K905087 TRIOS 02
    K903928 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
    K903929 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
    Search all 18 clearances from Biotronik, GmbH & Co. →