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510(k) Data Aggregation
K Number
K993463Device Name
INTRAVASCULAR ADMINISTRATION SET
Manufacturer
Date Cleared
2000-01-04
(83 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM ASSEMBLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.
Environment of use: Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated.
Device Description
The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.
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