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

    CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD

    K Number: K851897 · Decision Aug 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    26
    Review Days
    101

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
    K Number
    K851897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Control Systems, Inc.
    Date Received
    April 30, 1985
    Decision Date
    August 9, 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

    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 Cardiac Control Systems, Inc.

    K Number Device Name
    K971775 INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
    K946188 CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
    K950210 CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
    K923868 CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
    K905824 MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
    K904941 MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
    K895110 MAESTRO PACEMAKER TEST MAGNET
    K884023 MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
    K884024 POLYSAFE(TM) IMPLANTABLE PACING LEAD
    K883015 POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
    Search all 26 clearances from Cardiac Control Systems, Inc. →