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510(k) Data Aggregation
K Number
K221400Device Name
hygh-tec drainage
Manufacturer
Creative Balloons GmbH
Date Cleared
2023-02-09
(269 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Creative Balloons GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liguid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.
Device Description
The hygh-tec drainage is sold as a kit to include a main catheter component, collection bag, inflation syringe, and closure strap. The catheter component consists of a retaining and sealing balloon element, a trans-anal segment, drainage shaft, an elastically deformable tip, a colored positioning ring, a stool irrigation tube, an irrigation line, and an air filling line.
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