Sirolimus Coated Balloon Catheter - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class D

Sirolimus Coated Balloon Catheter

UID: MFG/MD/2020/000228_5410914391313a4558766d6188e5cd6f_554af346dfe2cd6725e28e152c25dfc6

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

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