BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    MEDTRONIC 8437/8438

    K Number: K843089 · Decision Aug 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    475
    Review Days
    23

    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
    MEDTRONIC 8437/8438
    K Number
    K843089
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Vascular
    Date Received
    August 6, 1984
    Decision Date
    August 29, 1984
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

    Similar 510(k) Clearances

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

    PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OPUS S MODEL 4121 AND 4124 PACEMAKERS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PIKOS LP 01, PIKOS LP E01

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular
    View all

    Other Clearances by Medtronic Vascular

    K Number Device Name
    K232570 Steerant™ Super Stiff Guidewire
    K232190 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
    K230156 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
    K220773 Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
    K192296 Medtronic 6F Taiga Guiding Catheter
    K173515 Admiral Xtreme
    K162097 InTRAkit
    K162027 TRAcelet Compression Device
    K161287 DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
    K133539 TOTAL ACROSS
    Search all 475 clearances from Medtronic Vascular →