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510(k) Data Aggregation

    K Number
    K961884
    Device Name
    CATH CADDIE
    Manufacturer
    Date Cleared
    1996-08-01

    (78 days)

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

    MARK-CLARK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The Cath Caddie was developed by the grandmother of a pediatric cancer patient who received chemotherapy via a Hickman Catheter Constant removal of taped dressings placed in his chest. resulted in skin irritations to the youth. The inventor created the Cath Caddie for her grandchild to eliminate the need for tape. Subsequently, she provided Cath Caddies for several additional patients of Dr. David Rosen. She estimates that Dr.Rosen has issued as many as 1,500 of the covers through his practice and through the Children's Miracle Network. Additional prototypes of the Cath Caddie were provided to Dr. Jerry H. Feagan who in turn passed them on to the Endoscopy and Surgery Center of Topeka. This practice utilized the Cath Caddie to cover and secure PEG tubes of enteral feeding tubes in the abdomens of some of their patients.
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