Sirolimus Coated PTA Balloon Catheter - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class D

Sirolimus Coated PTA Balloon Catheter

UID: MFG/MD/2020/000228_8fd9bfd852023fe8978f46410d28622c_69c4d7c8ad22ac551bdcedba9932dbe9

Brand Name

Focus np, Abluminus np, Cynosure

License Holder

Envision Scientific Pvt. Ltd.

Device Class

Class D

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.