PTA balloon dilatation catheter - India CDSCO Medical Device Registration
PTA balloon dilatation catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000166_d4514edf34f005b23d194a74ee1e76fd_dbac77740a658be3d5d37e18b3146b24. This device is marketed under the brand name iVascular restorer. The license holder is M/s. Luminor Medical Devices Pvt. Ltd. ,Unit No. EPO-03-007, 3rd Floor, Emaar Emerald Plaza, Sector 65, Gurugram ,Gurgaon Haryana ,122018 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
iVascular restorer
Device Class
Approving Authority
CDSCO
Product Information
IVascular oceanus 14 pro - The device is indicated to dilate stenosis in femoral, popliteal, infra-poplitealand renal arteries and for treating obstructive lesions of native or syntheticarteriovenous dialysis fistulae, with a reference diameter balloon from 1.25 and 4.0 mm and lengths from 10 up to 200 mm. IVascular oceanus 18 - The device is indicated to dilate stenoses in iliac, femoral, popliteal, infra-popliteal and renal arteries and for treating obstructive lesions of native orsynthetic arteriovenous dialysis fistulae, with a diameter from 2 to 8 mm and lengths from 20 up to 200mm. IVascular oceanus 35 - Indicated for dilation of stenosis located in the renal, iliac, femoral, poplitealand infrapopliteal arteries, and for treating obstructive lesions of native orsynthetic arteriovenous dialysis fistulae
CoCr Peripheral stent system
Brand: iVascular restorer
M/s. Luminor Medical Devices Pvt. Ltd. ,Unit No. EPO-03-007, 3rd Floor, Emaar Emerald Plaza, Sector 65, Gurugram ,Gurgaon Haryana ,122018 ,India
Self-expanding peripheral stent system
Brand: iVascular restorer
M/s. Luminor Medical Devices Pvt. Ltd. ,Unit No. EPO-03-007, 3rd Floor, Emaar Emerald Plaza, Sector 65, Gurugram ,Gurgaon Haryana ,122018 ,India
CoCr Peripheral stent system
Brand: iVascular restorer
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Self-expanding peripheral stent system
Brand: iVascular restorer
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