Paclitaxel eluting PTA balloon dilatation catheter - India CDSCO Medical Device Registration
Paclitaxel eluting PTA balloon dilatation catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000166_9d51e9ccbd7228b984d9ab31b90e3642_27192f1247de371fb32dede8881035f0. This device is marketed under the brand name iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35. 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 D. The approving authority is CDSCO.
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Brand Name
iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
Device Class
Approving Authority
CDSCO
Product Information
iVascular luminor 14m - The device is indicated to dilate stenosis in femoral, popliteal infra-popliteal arteries, with a reference diameter balloon from 1.5 and 4.0mm and lengths from 40 up to 200mm. iVascular luminor 18- The device is indicated for dilation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial, with a reference diameter balloon from 2 to 8 mm and lengths from 20 to 200 mm. It is also indicated for stent postdilation in the peripheral vascular system. iVascular luminor 35- The device is indicated for dilation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial, with a reference diameter balloon from 5 to 7 mm and lengths from 20 to 150 mm. It is also indicated for stent postdilation in the peripheral vascular system. Minor update to Instruction For Use: (iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35) addition of a warning regarding paclitaxel use; (iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35) Inclusion of a new section for summarizing the clinical outcomes of the clinical trials conducted on iVascular Luminor models
Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
M/s. Luminor Medical Devices Pvt. Ltd. ,Unit No. EPO-03-007, 3rd Floor, Emaar Emerald Plaza, Sector 65, Gurugram ,Gurgaon Haryana ,122018 ,India
Thrombus extraction catheter
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
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
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PTA balloon dilatation catheter
Brand: iVascular restorer
Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
Self-expanding peripheral stent system
Brand: iVascular restorer
Thrombus extraction catheter
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35