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510(k) Data Aggregation
K Number
K030549Device Name
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG
Manufacturer
GUIDCORP
Date Cleared
2003-05-14
(82 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
GUIDCORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices.
Device Description
The HI-TORQUE PILOT™ Guide Wire with Hydrocoat Hydrophilic Coating is a guide wire with a maximum diameter of 0.0140" and is available in 175 cm and 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TORQUE PILOT™ 200 Guide Wires). The distal tip of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference; the J shapes provide the physician the convenience of a J shape without manual shaping. Brachial and femoral markers are located on the proximal segment of the 190 cm and 300 cm guide wires to indicate when the tip of the guide wire is about to exit the guide catheter. The proximal section of the wire is coated with polytetrafluroethylene (PTFE). The distal, polyurethane-covered area, of the wire is coated with hydrocoat hydrophilic coating.
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