Catheter, Angioplasty, Balloon Dilatation - India CDSCO Medical Device Registration

Catheter, Angioplasty, Balloon Dilatation is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000129_bf85d322222f04bec9f79cbad06d0aac_5477f2308c10fe3f49bd020e5ad2529f. This device is marketed under the brand name Mustang PTA Balloon 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 B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Catheter, Angioplasty, Balloon Dilatation

UID: IMP/MD/2018/000129_bf85d322222f04bec9f79cbad06d0aac_5477f2308c10fe3f49bd020e5ad2529f

Brand Name

Mustang PTA Balloon 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

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Peripheral Cutting Balloon Device is indicated for PTA of obstructive lesions in peripheral vessels with a reference diameter ranging from 2 mm - 4 mm. The target lesion should possess the following characteristics: minimal tortuosity of proximal vessel segment, and be a nonangulated lesion segment (Mustang PTA Balloon Dilatation Catheter)