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510(k) Data Aggregation

    K Number
    K002650
    Device Name
    VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
    Manufacturer
    BENTEC MEDICAL, INC.
    Date Cleared
    2001-02-16

    (175 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971411
    Device Name
    DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K
    Manufacturer
    BENTEC MEDICAL, INC.
    Date Cleared
    1997-06-03

    (48 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
    Device Description
    Epistaxis Catheter
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    K Number
    K971517
    Device Name
    SILICONE PUTTY EAR PLUGS
    Manufacturer
    BENTEC MEDICAL, INC.
    Date Cleared
    1997-06-02

    (38 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silicone Putty Ear Plugs are used to block water from entering the ear canal.
    Device Description
    Silicone Putty Ear Plugs
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