CDSCO UID MFG/MD/2020/000257_7d4111768735b600b6f8e9422864d92e_7445fbbfb2a8108822d9cc41d9081894
Paclitaxel Drug Coated PTA Balloon()
Sahajanand Medical Technologies Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: 1.Supraflex, 2. Flexilimus, 3. Protolimus, 4. Vactaflex, 5. Supralimus-Flex, 6. Flexilimus Plus, 7. Protolimus Plus, 8. Vactaflex Plus, 9. Supralimus Flex Plus, 10. Aima Plus, 11. Abrax CoCr
Registration details
- UID
- MFG/MD/2020/000257_7d4111768735b600b6f8e9422864d92e_7445fbbfb2a8108822d9cc41d9081894
- Device class
- Class D
- Brand name
- 1.Supraflex, 2. Flexilimus, 3. Protolimus, 4. Vactaflex, 5. Supralimus-Flex, 6. Flexilimus Plus, 7. Protolimus Plus, 8. Vactaflex Plus, 9. Supralimus Flex Plus, 10. Aima Plus, 11. Abrax CoCr
- License holder
- Sahajanand Medical Technologies Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- The Paclitaxel drug coated PTA balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions up to 200 mm in length in native infrapopliteal arteries and popliteal arteries (1.Supraflex, 2. Flexilimus, 3. Protolimus, 4. Vactaflex, 5. Supralimus-Flex, 6. Flexilimus Plus, 7. Protolimus Plus, 8. Vactaflex Plus, 9. Supralimus Flex Plus, 10. Aima Plus, 11. Abrax CoCr) with reference vessel diameters of 2-12 mm
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About this record
Paclitaxel Drug Coated PTA Balloon() is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000257_7d4111768735b600b6f8e9422864d92e_7445fbbfb2a8108822d9cc41d9081894. This device is marketed under the brand name 1.Supraflex, 2. Flexilimus, 3. Protolimus, 4. Vactaflex, 5. Supralimus-Flex, 6. Flexilimus Plus, 7. Protolimus Plus, 8. Vactaflex Plus, 9. Supralimus Flex Plus, 10. Aima Plus, 11. Abrax CoCr. The license holder is Sahajanand Medical Technologies 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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