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510(k) Data Aggregation
K Number
K153502Device Name
ClariVein IC
Manufacturer
VASCULAR INSIGHTS, LLC
Date Cleared
2016-01-06
(30 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 Clari Vein IC is indicated for infusion of physician specified agents in the peripheral vasculature.
Device Description
The ClariVein IC is a specialty infusion catheter with 360°rotatable fluid dispersion wire connected to a proximally located integral battery powered motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features which facilitate physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The Clari Vein IC has no user serviceable parts or capital equipment. It is provided to the user sterile, for single patient use and is fully disposable.
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