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510(k) Data Aggregation

    K Number
    K964447
    Device Name
    PICC CATHETER/MIDLINE CATHETER
    Manufacturer
    Date Cleared
    1997-04-16

    (161 days)

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

    MENLO CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy.
    Device Description
    Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy. Method of insertion is through an introducer sheath. The optimal catheter tip location for the PICC catheter is in the superior vena cava of the heart. The recommended tip location for the midline catheter is below the shoulder, at the level of the axilla. The products will be available in single and dual lumen configurations; with and without a flushable guidewire; and as sterile individual units or in insertion kits containing the components used for insertion of the device.
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    K Number
    K951620
    Device Name
    MIDMARK MIDLINE CATHETER
    Manufacturer
    Date Cleared
    1996-04-04

    (363 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENLO CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Peripherally inserted catheter for venous access or intravenous therapy.
    Device Description
    Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla. The products will be available in single and dual lumen configurations, as sterile individual units or in trays along with the components used for insertion.
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