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

    BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE

    K Number: K990284 · Decision Feb 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    19
    Applicant Total
    28
    Review Days
    734

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    Basic Information

    Device Name
    BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
    K Number
    K990284
    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
    January 29, 1999
    Decision Date
    February 1, 2001
    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
    K111523 OSTEOCOOL (TM) RF ABLATION SYSTEM
    K102948 TORFLEX TRANSSEPTAL GUIDING SHEATH
    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. →