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

    IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY

    K Number: K854997 · Decision Feb 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    107
    Review Days
    62

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    Basic Information

    Device Name
    IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
    K Number
    K854997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Telectronics, Inc.
    Date Received
    December 12, 1985
    Decision Date
    February 12, 1986
    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 Telectronics, Inc.

    K Number Device Name
    K890895 IMPLANTABLE ADAPTOR 033-380
    K891231 OPTIMA MPT AND SPT PACEMAKERS
    K890350 VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
    K884411 OPTIMA MPT AND SPT PACEMAKERS
    K884278 IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
    K881837 OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
    K874664 IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
    K864712 MODEL 1740 PERSONAL POCKET PROGRAMMER
    K872766 IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
    K865098 SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
    Search all 107 clearances from Telectronics, Inc. →