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CDSCO UID IMP/MD/2018/000061_bc1d26787fa62db29953d92b22e48ae4_0c4e09efa3a64c76b6baa2b9faa31cab

Catheter, Angioplasty, Balloon Dilatation, basic, Single Use device

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_bc1d26787fa62db29953d92b22e48ae4_0c4e09efa3a64c76b6baa2b9faa31cab
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 Emerge Monorail PTCA Dilation Catheters (NC Quantum Apex Monorail PTCA Dilatation Catheter) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Monorail PTCA Dilatation Catheters (NC Quantum Apex Monorail PTCA Dilatation Catheter) are 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 device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_bc1d26787fa62db29953d92b22e48ae4_0c4e09efa3a64c76b6baa2b9faa31cab. 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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