BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75

    K Number: K031949 · Decision Dec 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    19
    Applicant Total
    28
    Review Days
    169

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    Basic Information

    Device Name
    TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
    K Number
    K031949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5175
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baylis Medical Co., Inc.
    Date Received
    June 24, 2003
    Decision Date
    December 10, 2003
    Product Code
    DXF
    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
    DXF Catheter, Septostomy

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    Other Clearances by Baylis Medical Co., Inc.

    K Number Device Name
    K122926 SUREFLEX STEERABLE GUIDING SHEATH KIT
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    K102192 INDISCAL DIGITAL MANOMETER
    K101372 DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
    K101615 POWERWIRE RADIOFREQUENCY GUIDEWIRE
    K101117 LEV-OR DILATION CATHETER OTW
    K092877 INDISCAL ASPIRATION DEVICE AND ACCESSORIES
    K092337 PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
    K073326 NRG TRANSSEPTAL NEEDLE
    Search all 28 clearances from Baylis Medical Co., Inc. →