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

    OPTIMA MPT MODEL 5281E AND MODEL 5282E

    K Number: K897116 · Decision Mar 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    20
    Review Days
    78

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    Basic Information

    Device Name
    OPTIMA MPT MODEL 5281E AND MODEL 5282E
    K Number
    K897116
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Telectronics Pacing Systems, Inc.
    Date Received
    December 26, 1989
    Decision Date
    March 14, 1990
    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

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    Other Clearances by Telectronics Pacing Systems, Inc.

    K Number Device Name
    K961118 MAXIM PF MODELS 033-581/033-590
    K943657 STERILIZATION
    K934899 BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
    K926340 NEW LEAD INTRODUCER KITS, VARIOUS MODELS
    K914489 NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
    K913919 UNIVERSAL TERMINAL CAP, 3.2MM
    K912773 UNIPOLAR UPSIZING ADAPTOR
    K911273 100 CM PERMANENT PACING LEAD MODELS
    K910112 BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
    K903186 OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
    Search all 20 clearances from Telectronics Pacing Systems, Inc. →