BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TRACHEOSTOMY CARE TRAY

    K Number: K862663 · Decision Jul 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    16

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    Basic Information

    Device Name
    TRACHEOSTOMY CARE TRAY
    K Number
    K862663
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Welmed Systems, Inc.
    Date Received
    July 14, 1986
    Decision Date
    July 30, 1986
    Product Code
    LRQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRQ Tracheostomy And Nasal Suctioning Kit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LRQ), ordered by most recent decision date.

    TRACHEOSTOMY KIT

    FDA 510(k)
    FDA Class 1 ·Unknown

    MEDCARE TRACHEOSTOMY CARE TRAY

    FDA 510(k)
    FDA Class 1 ·Unknown

    READY NURSE SYSTEM (RNS) TRACH CARE KIT

    FDA 510(k)
    FDA Class 1 ·Unknown

    GENT-L-KARE TRACHEOSTOMY TRAYS

    FDA 510(k)
    FDA Class 1 ·Unknown

    TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1

    FDA 510(k)
    FDA Class 1 ·Unknown
    View all

    Other Clearances by Welmed Systems, Inc.

    K Number Device Name
    K863282 CARE + PLUS CATHETER CARE TRAY
    K863281 CARE + PLUS IRREGATION TRAY
    K863497 SUCTION CATHETER KIT
    K863284 I.V. START KIT
    K863283 CARE + PLUS SUTURE REMOVAL TRAY
    K862219 T.P.N. DRESSING CHANGE TRAY