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 G/28/1396_5410914391313a4558766d6188e5cd6f_f71e16fe3b2128ee8a858cecb5ed5690. This device is marketed under the brand name Devoir, Vanquisher. 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: G/28/1396_5410914391313a4558766d6188e5cd6f_f71e16fe3b2128ee8a858cecb5ed5690

Brand Name

Devoir, Vanquisher

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 intended for use in the treatment of patients with clinical symptoms of myocardial ischemia related to the pathological condition of one or more coronary arteries. Sirolimus Coated Balloon Catheter is therefore indicated to dilate the diseased segment(Devoir, Vanquisher) and deliver drug in a coronary artery or a graft, to improve myocardial perfusion with lesion lengths ranging from 10.00 to 40.00 mm and diameters ranging from 1.50 mm to 4.00 mm