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_9d88c541d815e1612d2d85c6de4cfa8f. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Drug Coated Balloon PTA Catheter

UID: IMP/MD/2021/000088_70851186971c0930340b49c9c9121a77_9d88c541d815e1612d2d85c6de4cfa8f

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 014 Drug Coated Balloon Catheter is intended for use as a PTA catheter to dilate stenotic or obstructive vascular lesions in the lower extremities, for the purpose of improving limb perfusion and decreasing the incidence of restenosis.