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510(k) Data Aggregation
K Number
K961884Device Name
CATH CADDIE
Manufacturer
Date Cleared
1996-08-01
(78 days)
Product Code
Regulation Number
876.5980Why 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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