Sirolimus Coated Balloon Catheter
- UID
- G/28/1396_5410914391313a4558766d6188e5cd6f_f71e16fe3b2128ee8a858cecb5ed5690
- Device class
- Class D
- Brand name
- Devoir, Vanquisher
- License holder
- Envision Scientific Pvt. Ltd.
- 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
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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