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Intravascular Haemodynamic Monitoring System Guidewire - India CDSCO Medical Device Registration

Intravascular Haemodynamic Monitoring System Guidewire is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_8756b0b026607f0fa6c34b7f026bd27c_a61f049eb3648c88820c3303d9f1cdc6. This device is marketed under the brand name NC Quantum Apex Monorail PTCA Dilatation Catheter. 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 D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Intravascular Haemodynamic Monitoring System Guidewire
UID: IMP/MD/2018/000061_8756b0b026607f0fa6c34b7f026bd27c_a61f049eb3648c88820c3303d9f1cdc6

Brand Name

NC Quantum Apex Monorail PTCA Dilatation Catheter

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Comet Pressure Guidewire measures blood pressure gradient across coronary lesions during endovascular procedures. Comet pressure guidewire may also be used as a coronary guidewire for interventional treatments. Comet pressure guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary blood vessels

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