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Peripheral Vascular Guidewire - India CDSCO Medical Device Registration

Peripheral Vascular Guidewire is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000122_765210722c0a12a35396dbb692624261_5c4030f2a7794bc4bf0c08bbc4f14396. This device is marketed under the brand name V-14 ControlWire Guidewire with ICE Hydrophilic Coating. The license holder is Boston Scientific India Private Limited ,C/o Parekh Integrated Services Pvt.Ltd., 1st Floor, Khasra Nos. 9//12/3 min (3-17), 13/3min (5-7), 18(8-0), 19min (5-16), 22min (5-16), 23(8-0), 13//2min (5-16), 3 (8-0), Village Bhangrola, Sector M-12 ,Gurgaon Haryana ,122505 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Peripheral Vascular Guidewire
UID: IMP/MD/2021/000122_765210722c0a12a35396dbb692624261_5c4030f2a7794bc4bf0c08bbc4f14396

Brand Name

V-14 ControlWire Guidewire with ICE Hydrophilic Coating

Device Class

Class B

Approving Authority

CDSCO

Product Information

The V-18 Control Wire guidewire is available in 110, 150, 200 and 300 cm lengths. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is intended for peripheral use only. A torque device (V-14 ControlWire Guidewire with ICE Hydrophilic Coating) is included with each wire to facilitate directional manipulation of the guidewire. The 110 cm V-18 Control Wire guidewire is intended for general intravascular use including the placement of PTA balloon catheters requiring an 0.018 in guidewire in hemodialysis AV access procedures. The 150, 200 and 300 cm V-18 Control Wire guidewire are intended for general intravascular use

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