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Coronary angioplasty balloon catheter, basic - India CDSCO Medical Device Registration

Coronary angioplasty balloon catheter, basic is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_41a3e34e213fc63f816818b1a22e354e_285076d0360bc4a01efdbd8f59b0112e. 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
Coronary angioplasty balloon catheter, basic
UID: IMP/MD/2018/000061_41a3e34e213fc63f816818b1a22e354e_285076d0360bc4a01efdbd8f59b0112e

Brand Name

NC Quantum Apex Monorail PTCA Dilatation Catheter

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Maverick2 Monorail PTCA Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Maverick2 Monorail PTCA Dilatation Catheter (NC Quantum Apex Monorail PTCA Dilatation Catheter) is also indicated for the post-delivery expansion of balloon expandable stents

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