Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K971615
    Device Name
    PATTISON ESOPHAGEAL DILATOR
    Date Cleared
    1997-07-24

    (83 days)

    Product Code
    Regulation Number
    876.5365
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRI-MED SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K970890
    Device Name
    #ES-32 SUCTION CATHETER 32 FR.
    Date Cleared
    1997-05-23

    (73 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRI-MED SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tri-Med #ES-32 Suction Catheter is to be used to suction liquids and solids from the stomach and esophagus when deemed necessary by the physician.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K970982
    Device Name
    T-RX RETRIEVAL FORCEPS
    Date Cleared
    1997-05-09

    (52 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRI-MED SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1