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

    ADAPTAID ELEMA LEAD ADAPTER KIT 365-17

    K Number: K801038 · Decision Jul 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    102
    Applicant Total
    211
    Review Days
    67

    Basic Information

    Device Name
    ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
    K Number
    K801038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    INTERMEDICS, INC.
    Date Received
    May 2, 1980
    Decision Date
    July 8, 1980
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DTD), ordered by most recent decision date.

    IS4/DF4 Port Plug

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    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. →