Paclitaxel Coated Balloon Catheter
- UID
- MFG/MD/2020/000236_bbbb947099514904ac6dff6339d802e0_3dca6d1fd3548aeb86c0eeaee8cdc8d9
- Device class
- Class D
- Brand name
- EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
- License holder
- Nano Therapeutics Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Paclitaxel Coated PTCA balloon catheter is intended for treatment of atherosclerotic depositions in coronary lesions, specifically in patients with either in-stent restenosis or de novo coronary lesions with a reference vessel diameter ranging from 1.50 mm to 4.50 mm and lesion lengths up to 41 mm and it is also intended for pre and post dilatation during coronary stent implantation for improving luminal diameter. Paclitaxel Coated PTA balloon catheter is intended for treatment of atherosclerotic depositions in peripheral lesions, specifically in patients with either in-stent restenosis or de novo peripheral lesions with a reference vessel diameter ranging from 2.00 mm to 12.00 mm and lesion lengths up to 200 mm and it is also intended for pre and post dilatation during peripheral stent implantation for improving luminal diameter
Paclitaxel Coated Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000236_bbbb947099514904ac6dff6339d802e0_3dca6d1fd3548aeb86c0eeaee8cdc8d9. This device is marketed under the brand name EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL. The license holder is Nano Therapeutics Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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