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

    NEW LEAD INTRODUCER KITS, VARIOUS MODELS

    K Number: K926340 · Decision May 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    20
    Review Days
    161

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    Basic Information

    Device Name
    NEW LEAD INTRODUCER KITS, VARIOUS MODELS
    K Number
    K926340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Telectronics Pacing Systems, Inc.
    Date Received
    December 17, 1992
    Decision Date
    May 27, 1993
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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    Other Clearances by Telectronics Pacing Systems, Inc.

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    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
    K904741 LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
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