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510(k) Data Aggregation
K Number
K110553Device Name
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
Manufacturer
ASAHI INTECC USA, INC.
Date Cleared
2011-03-18
(18 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
ASAHI INTECC USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASAHI Treasure Floppy Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Device Description
The ASAHI Treasure Floppy Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a stainless steel and platinum-nickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature. A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.
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