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Catheter, Angioplasty, Balloon Dilatation, basic, Single Use device - India CDSCO Medical Device Registration

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/2019/000130_bc1d26787fa62db29953d92b22e48ae4_1cf2eabf33b7efacee47c270a4d594a3. This device is marketed under the brand name NC Emerge Monorail PTCA Dilatation Catheter. The license holder is Boston Scientific India Pvt. Ltd.,, 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 device
UID: IMP/MD/2019/000130_bc1d26787fa62db29953d92b22e48ae4_1cf2eabf33b7efacee47c270a4d594a3

Brand Name

NC Emerge Monorail PTCA Dilatation Catheter

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Emerge Monorail PTCA Dilation Catheters (NC Emerge 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 Emerge Monorail PTCA Dilatation Catheter) are also indicated for the post-delivery expansion of balloon expandable stents (NC Emerge Monorail PTCA Dilatation Catheter)

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