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

    MINI-TRACH KIT

    K Number: K862167 · Decision Aug 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    20
    Review Days
    58

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    Basic Information

    Device Name
    MINI-TRACH KIT
    K Number
    K862167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Portex, Inc.
    Date Received
    June 9, 1986
    Decision Date
    August 6, 1986
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

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    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

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    Other Clearances by Portex, Inc.

    K Number Device Name
    K033080 PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
    K031057 PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
    K023793 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
    K014115 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
    K014073 HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
    K873992 LARYNGECTOMY TUBE
    K874597 THERMOVENT 600, 1200, T, 02
    K842456 JET VENTILATION ADAPTOR
    K833908 IRRI-CATH
    K840015 SWIVEL ADAPTOR W/ALARM PORT
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