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510(k) Data Aggregation

    K Number
    K992424
    Device Name
    SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
    Date Cleared
    2000-12-29

    (527 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLASTIMED LABORATOIRE PHARMACEUTIQUE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Plastimed's Seldiflex® central venous catheter is intended for long-term vascular access and is indicated for use with patients who require central venous pressure monitoring, I.V. fluids, blood products, drugs, or parenteral nutrition solutions.
    Device Description
    The Seldiflex® is a single lumen, radiopaque polyurethane, long-term central venous catheter. Its accessories include a protective adapter female cap, introducer needle, needle obturator, double-ended J guidewire, scalpel, catheter clamp, rigid fastener, a vessel dilator, and silver Dacron® cuff.
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    K Number
    K974642
    Device Name
    COMBICATH CATHETER
    Date Cleared
    1998-03-13

    (88 days)

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

    PLASTIMED LABORATOIRE PHARMACEUTIQUE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalvestar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis. The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.
    Device Description
    The COMBICATH Catheter, is a radiopaque, double plugged, telescoping catheter designed to capture bronchoalveolar secretion samples in mechanically ventilated patients.
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