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510(k) Data Aggregation
K Number
K014195Device Name
KAYAK HYDROPHILIC GUIDE WIRES
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2002-03-19
(88 days)
Product Code
DOX
Regulation Number
862.3550Why did this record match?
Product Code :
DOX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.
Device Description
The Kayak™ Hydrophilic Guide Wires are steerable guide wires available in a nominal diameter of 0.035 and 0.038 inches and nominal lengths of 80, 150 and 180 centimeters. The available tip flexibilities will be • Standard, • Stiff • Long Taper. The distal three centimeters of all models are available in straight and pre-formed angled tip design. The Kayak™ Hydrophilic Guide Wire consists of the following three components: • nickel titanium core • polyurethane jacket • hydrophilic coating. The full length of the guide wire has a polyurethane jacket containing tungsten encasing the core wire. The full length of the guide wire has a hydrophilic coating for lubricity.
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