Drug Coated Balloon PTA Catheter - India CDSCO Medical Device Registration

Drug Coated Balloon PTA Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000088_70851186971c0930340b49c9c9121a77_4aad46bcdccca3cb27b790e1b7caa39d. This device is marketed under the brand name Lutonix 035 Drug Coated Balloon PTA Catheter. The license holder is Bard India Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Drug Coated Balloon PTA Catheter

UID: IMP/MD/2021/000088_70851186971c0930340b49c9c9121a77_4aad46bcdccca3cb27b790e1b7caa39d

Brand Name

Lutonix 035 Drug Coated Balloon PTA Catheter

License Holder

Bard India Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Lutonix 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (Lutonix 035 Drug Coated Balloon PTA Catheter) in the peripheral vasculature and for the treatment of obstructive lesions and decreasing the incidence of restenosis. In addition, the Lutonix 035 Drug Coated Balloon Catheter is intended for PTA of native dialysis fistulae or synthetic grafts, opening narrowing and immature fistulae, to improve blood flow, and decreasing the incidence of restenosis