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510(k) Data Aggregation

    K Number
    K992476
    Device Name
    PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    2000-09-13

    (415 days)

    Product Code
    MWS, MMS
    Regulation Number
    870.4500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.
    Device Description
    Pilling Weck Surgical Stabilizer Removable Pads
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    K Number
    K992174
    Device Name
    PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    2000-03-23

    (269 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.
    Device Description
    Aortic Spoon Jaw Clamp
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    K Number
    K990935
    Device Name
    JACKSON ESOPHAGEAL DILATOR
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    1999-05-17

    (59 days)

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

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for exploratory and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.
    Device Description
    Device consists of silicone tip, stainless steel rod and nylon sleeve.
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    K Number
    K990561
    Device Name
    OPTICAL FORCEPS
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    1999-05-14

    (81 days)

    Product Code
    JEK, EOX, EWY
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes
    Device Description
    The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep
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    K Number
    K982128
    Device Name
    SHIKANI-FRENCH SPEAKING VALVE
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    1998-10-23

    (128 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To allow airflow over the vocal cords for speaking To be used only as an attachment to CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.
    Device Description
    The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.
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