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CDSCO UID IMP/MD/2021/000122_765210722c0a12a35396dbb692624261_5c4030f2a7794bc4bf0c08bbc4f14396

Peripheral Vascular Guidewire

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·Device Class Class B·India CDSCO·Brand: V-14 ControlWire Guidewire with ICE Hydrophilic Coating
Registration details
UID
IMP/MD/2021/000122_765210722c0a12a35396dbb692624261_5c4030f2a7794bc4bf0c08bbc4f14396
Device class
Class B
Brand name
V-14 ControlWire Guidewire with ICE Hydrophilic Coating
License holder
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
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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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
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About this record

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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