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510(k) Data Aggregation
K Number
K062308Device Name
LMT-KATH-S; LMT-KATH-I
Manufacturer
Date Cleared
2007-03-20
(224 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LICHER MEDIZINTECHNOLOGIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LMT-KATH-S and LMT-KATH-I Infusion Sets are indicated for the infusion and/or injection of medication that is dispensed by means of micro-dosage pump into the body below the surface of the skin. These sets are intended to be used with manual injection and infusion and automated infusion with infusion pumps.
Device Description
The LMT-KATH-S and LMT-KATH-I infusion sets are administration sets intended to deliver medications under the skin. Both connect at the female Luer to a reservoir, which, for example, can be delivered through the use of an external infusion pump or by medical injection. The stainless steel cannula is inserted into the subcutaneous tissue and fixed into place by an attached approximate circular disk bandage with medical grade adhesive. The tubing of both infusion sets is made of polyethylene. The LMT-KATH-S and LMT-KATH-I infusion sets have identical components that allow the set to be disconnected/connected approximately 60 cm / 23.62″ from the insertion site. The disconnect mechanism (Luer connector) on the reservoir side has a protector cap to maintain clean conditions during disconnection and to cover the connector. The tube may have additional bandages with medical adhesive grade.
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