Sirolimus Coated PTA Balloon Catheter
- UID
- MFG/MD/2020/000228_8fd9bfd852023fe8978f46410d28622c_a9609e37381790444293f7822fc68992
- Device class
- Class C
- Brand name
- Nile SIR, Bifur
- License holder
- Envision Scientific Pvt. Ltd.
- 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.
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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