Drug Coated Balloon PTA Catheter
- UID
- IMP/MD/2021/000461_70851186971c0930340b49c9c9121a77_9d88c541d815e1612d2d85c6de4cfa8f
- Device class
- Class C
- Brand name
- Lutonix 035 Drug Coated Balloon PTA Catheter
- License holder
- Becton Dickinson India Private Limited
- 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.
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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