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

    MODEL 366-07 ADAPT AID LEAD ADAPTER

    K Number: K822704 · Decision Nov 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    211
    Review Days
    78

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    Basic Information

    Device Name
    MODEL 366-07 ADAPT AID LEAD ADAPTER
    K Number
    K822704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Intermedics, Inc.
    Date Received
    September 7, 1982
    Decision Date
    November 24, 1982
    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 Intermedics, Inc.

    K Number Device Name
    K954610 MODEL 430-07 ENDOCARDIAL PACING LEAD
    K955122 INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
    K962174 BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
    K955550 CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
    K960281 IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
    K954719 INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
    K933278 INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
    K922042 CARDIFIX ENDOCARDIAL PACING LEAD
    K922972 MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
    K920530 INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
    Search all 211 clearances from Intermedics, Inc. →