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510(k) Data Aggregation
K Number
K071468Device Name
CLARIVEIN CATHETER
Manufacturer
VASCULAR INSIGHTS LLC
Date Cleared
2008-03-20
(296 days)
Product Code
KRA
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR INSIGHTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClariVein™ Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature.
Device Description
The ClariVein™ Infusion Catheter (ClariVein™-IC) is an infusion catheter system designed to introduce physician-specified medicaments into the peripheral vasculature. Infusion is through an opening at the distal end of the catheter and fluid delivery is enhanced by the use of a rotating dispersion wire to mix and disperse the infused fluid in the blood stream and on the vessel wall. The dispersion wire, connected to an interface cartridge for proximal connection to the motorized handle, extends through the catheter lumen. Prior to drug infusion the catheter sheath is inserted into the vasculature and once the catheter tip is positioned at the treatment site, the catheter sheath is retracted to expose the dispersion wire tip. Wire rotation is controlled by a 9V DC motorized Handle Unit. The Handle Unit also provides a grip and syringe holder to facilitate physiciancontrolled infusion.
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