Self-expanding peripheral stent system - India CDSCO Medical Device Registration
Self-expanding peripheral stent system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000166_7eca113e3ec538e36c69b18bddacdc32_da22da954d5d5f106c20d94c79935ac5. 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
The peripheral stent system is indicated for the treatment of de novo or restenotic atherosclerotic lesions in peripheral arteries located under the aortic arch; that is, and for palliation of biliary tract malignant stenosis with a nominal diameter ranging from 4.5 and 9.5 mm.
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
PTA balloon dilatation catheter
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: Nitinol
M/s Luminor Medical Devices Private Limited
CoCr Peripheral stent system
Brand: iVascular restorer
PTA balloon dilatation catheter
Brand: iVascular restorer
Paclitaxel eluting PTA balloon dilatation catheter
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
Thrombus extraction catheter
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35