Sirolimus Coated Balloon Catheter
- UID
- MFG/MD/2020/000228_5410914391313a4558766d6188e5cd6f_554af346dfe2cd6725e28e152c25dfc6
- 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
- Sirolimus Coated Balloon Catheter is indicated for treatment of Coronary Artery Disease by performing Percutaneous Transluminal Coronary Angioplasty, after appropriate lesion preparation. Sirolimus Coated Balloon Catheter is therefore indicated to dilate the diseased segment(Focus np, Abluminus np, Cynosure) in coronary artery by delivering drug in coronary artery or graft with lesion lengths of 6.00 mm to 36.00 mm and reference vessel diameter from 1.50 mm to 4.00 mm
Sirolimus Coated Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000228_5410914391313a4558766d6188e5cd6f_554af346dfe2cd6725e28e152c25dfc6. 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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