Drug Coated Balloon PTA Catheter
- UID
- IMP/MD/2021/000088_70851186971c0930340b49c9c9121a77_4aad46bcdccca3cb27b790e1b7caa39d
- Device class
- Class C
- Brand name
- Lutonix 035 Drug Coated Balloon PTA Catheter
- License holder
- Bard India Healthcare Pvt. Ltd.
- 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
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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