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/2021/000461_70851186971c0930340b49c9c9121a77_9d88c541d815e1612d2d85c6de4cfa8f. This device is marketed under the brand name Lutonix 035 Drug Coated Balloon PTA Catheter. The license holder is Becton Dickinson India Private Limited, 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/2021/000461_70851186971c0930340b49c9c9121a77_9d88c541d815e1612d2d85c6de4cfa8f

Brand Name

Lutonix 035 Drug Coated Balloon PTA Catheter

License Holder

Becton Dickinson India Private Limited

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.