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_a9609e37381790444293f7822fc68992. This device is marketed under the brand name Nile SIR, Bifur. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Sirolimus Coated PTA Balloon Catheter

UID: MFG/MD/2020/000228_8fd9bfd852023fe8978f46410d28622c_a9609e37381790444293f7822fc68992

Brand Name

Nile SIR, Bifur

License Holder

Envision Scientific Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Xtreme Touch Neo (Nile SIR, Bifur) Sirolimus Coated Balloon Catheters (Nile SIR, Bifur) is indicated for treatment of patients with stenotic or obstructive vascular lesions (Nile SIR, Bifur) in the lower extremities for the purpose of improving limb perfusion and decreasing the incidence of restenosis in native Femoropopliteal arteries having reference vessel diameters of 1.50 mm to 12.0 mm.