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510(k) Data Aggregation
K Number
K032411Device Name
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
Manufacturer
JS VASCULAR, INC.
Date Cleared
2003-10-07
(63 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
JS VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use as a torque device for guidewires with a diameter of 0.014 --0.038" to facilitate twisting and advancing the guidewire during a procedure.
Device Description
The JS Vascular Guide Wire Vise™ is a sterile single-use wire vise/torque device consisting of a dual pin vise clamp construction. Guidance and tracking of a guidewire through the coronary or peripheral vasculature is accomplished by manual manipulation of the vise.
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