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

    NASOPHARYNGEAL AIRWAY

    K Number: K921353 · Decision Jun 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    122
    Registration Numbers
    122
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    84

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NASOPHARYNGEAL AIRWAY
    K Number
    K921353
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5100
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coast Medical Corp.
    Date Received
    March 19, 1992
    Decision Date
    June 11, 1992
    Product Code
    BTQ
    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
    BTQ Airway, Nasopharyngeal

    Similar 510(k) Clearances

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

    AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ROBERTAZZI NASOPHARYNGEAL AIRWAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    POLAMEDCO NASOPAHARYNGEAL AIRWAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SUNDERLAND NASAL TUBE

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

    Other Clearances by Coast Medical Corp.

    K Number Device Name
    K930929 ESOPHAGEAL STETHOSCOPE
    K930930 COAST MEDICAL, INC. RECTAL PROBE
    K925781 DISPOSABLE CUFFED ENDOTRACHEAL TUBE
    K925855 DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
    K921077 DISPOSABLE INTUBATION KITS