Sirolimus Coated PTA Balloon Catheter
- UID
- MFG/MD/2020/000228_8fd9bfd852023fe8978f46410d28622c_69c4d7c8ad22ac551bdcedba9932dbe9
- Device class
- Class D
- Brand name
- Focus np, Abluminus np, Cynosure
- License holder
- Envision Scientific Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Magic Touch - AVF device is a drug coated balloon catheter which is intended for use in the percutaneous transluminal angioplasty (Focus np, Abluminus np, Cynosure), after pre-dilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae and graft that are 3.00 mm to 12.00 mm in diameter and up to 95 mm in lesion length.
Sirolimus Coated PTA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000228_8fd9bfd852023fe8978f46410d28622c_69c4d7c8ad22ac551bdcedba9932dbe9. This device is marketed under the brand name Focus np, Abluminus np, Cynosure. The license holder is Envision Scientific 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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