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

    NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING

    K Number: K914489 · Decision Aug 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    20
    Review Days
    314

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    Basic Information

    Device Name
    NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
    K Number
    K914489
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Telectronics Pacing Systems, Inc.
    Date Received
    October 8, 1991
    Decision Date
    August 17, 1992
    Product Code
    DTB
    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
    DTB Permanent Pacemaker Electrode

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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
    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
    K904741 LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
    Search all 20 clearances from Telectronics Pacing Systems, Inc. →