Sirolimus Coated PTA Balloon catheter
- UID
- G/28/1396_ef0893d89cc26000d83d84f91013424a_0f34167a53182ee38ac90b64354db223
- 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 PTA 0.014'' OTW balloon catheter is intended to use in dilatation of stenosis in the iliac, femoral, ilio‐femoral, popliteal, infro‐popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. • Sirolimus coated PTA 0.018'' OTW catheter is intended for use in dilatation of peripheral arteries, such as the iliac, femoral, ilio‐femoral, popliteal, infra popliteal and renal arteries. • Sirolimus coated PTA 0.035'' OTW catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. • Sirolimus coated PTA 0.014'' RX dilatation catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infrapopliteal, renal and carotid arteries
Sirolimus Coated PTA Balloon catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID G/28/1396_ef0893d89cc26000d83d84f91013424a_0f34167a53182ee38ac90b64354db223. 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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