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Catheter, Angioplasty, Balloon Dilatation, basic, Single use devices - India CDSCO Medical Device Registration

Catheter, Angioplasty, Balloon Dilatation, basic, Single use devices is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_ea789f6e75af97f71e2948c578509c7f_07351a4d3780ce3fa9f429d687a5eb5f. 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
Catheter, Angioplasty, Balloon Dilatation, basic, Single use devices
UID: IMP/MD/2018/000061_ea789f6e75af97f71e2948c578509c7f_07351a4d3780ce3fa9f429d687a5eb5f

Brand Name

NC Quantum Apex Monorail PTCA Dilatation Catheter

Device Class

Class D

Approving Authority

CDSCO

Product Information

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

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