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_123aba305534f1437b31218b58fe8965. 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_123aba305534f1437b31218b58fe8965

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 Percutaneous Transluminal Angioplasty (Mustang PTA Balloon Dilatation Catheter) of obstructive lesions in peripheral vessels. The target lesion should possess the following characteristics: minimal tortuosity of proximal vessel segment, and be a non-angulated lesion segment (Mustang PTA Balloon Dilatation Catheter).