Guide Wire - India CDSCO Medical Device Registration

Guide Wire is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000350_d69bc356951cb011ba7eb177911663b8_905feb9c735913c2b23da52e80f4025e. This device is marketed under the brand name HI-TORQUE INFILTRAC Guide Wire , HI-TORQUE INFILTRAC PLUS Guide Wire. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Guide Wire

UID: IMP/MD/2020/000350_d69bc356951cb011ba7eb177911663b8_905feb9c735913c2b23da52e80f4025e

Brand Name

HI-TORQUE INFILTRAC Guide Wire , HI-TORQUE INFILTRAC PLUS Guide Wire

License Holder

Abbott Healthcare Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

This HI-TORQUE™ Guide Wire is indicated to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (HI-TORQUE INFILTRAC Guide Wire , HI-TORQUE INFILTRAC PLUS Guide Wire) and percutaneous transluminal angioplasty (HI-TORQUE INFILTRAC Guide Wire , HI-TORQUE INFILTRAC PLUS Guide Wire). This guide wire may also be used with compatible stent devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature

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