Search Results
Found 1 results
510(k) Data Aggregation
K Number
K140576Device Name
Y WIRE 2
Manufacturer
Date Cleared
2014-05-20
(75 days)
Product Code
Regulation Number
888.4540Why did this record match?
Product Code :
HXI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Y - Wire2 guidewire is intended for use by surgeons to assist with the proper introduction and placement of orthopedic instruments and implants.
Device Description
The Y-Wire 2 is an orthopedic guidewire with a distinctive distal split tip that is designed to prevent inadvertent advancement of the wire in tissue. Upon exiting a cannula, the distal tips will deploy to stop further advancement past the desired location. By design the distal tip is splayed 300 decrees for a distance of 11mm. The guidwire is made of Nitinol. The Y-Wire 2 is manufactured in five (5) diameters: 1.10mm, 1.40mm, 1.45mm and 1.50mm all have the same length of 560mm.
Ask a Question
Ask a specific question about this device
Page 1 of 1