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510(k) Data Aggregation
K Number
K112674Device Name
NAVIS TORQUER
Manufacturer
Date Cleared
2012-07-06
(296 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NAVIS MEDICAL,INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Navis Torquer is intended to facilitate guide wire manipulation during interventional procedures.
Device Description
The Navis Torquer is a guide wire accessory intended to assist with the manipulation and placement of guide wires during interventional procedures. It accommodates guide wires with diameters from 0.010 to 0.038 inches and is composed of the following two components: 1) a polycarbonate cylindrical body and collet; and 2) an acetal rotatable cap.
The side-entry design of the device allows single-handed operation. To mount the device on a guide wire, the cylinder body is rotated into the cap until a tactile 'click' is felt and the longitudinal slots in both parts are aligned, the device is then mounted on the guide wire. Holding the guide wire stationary, the device is rotated onto the guide wire until the guide wire is aligned within the center of the device. The device is positioned optimally on the guide wire and then secured by rotation of the cap or cylinder body. As the cap is rotated on the body, the collet grips the guide wire.
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