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CDSCO UID IMP/MD/2018/000061_3e4b231911fe34b21c22f648c3b38ece_27775d175bf483307e321be545903e27

Catheter, Angioplasty, Balloon Dilatation, basic; Single Use devices

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 D·India CDSCO·Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
Registration details
UID
IMP/MD/2018/000061_3e4b231911fe34b21c22f648c3b38ece_27775d175bf483307e321be545903e27
Device class
Class D
Brand name
NC Quantum Apex Monorail PTCA Dilatation Catheter
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 NC Emerge MR PTCA Dilatation Catheter 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 in patients with atherosclerosis. The NC Emerge MR PTCA Dilatation Catheter (NC Quantum Apex Monorail PTCA Dilatation Catheter) is also indicated for the post-delivery expansion of balloon expandable stents (NC Quantum Apex Monorail PTCA Dilatation Catheter)
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About this record

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_3e4b231911fe34b21c22f648c3b38ece_27775d175bf483307e321be545903e27. 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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