Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer - India CDSCO Medical Device Registration
Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000166_95a1678a882ce75f273e1b9a5a4f4e1a_ee4d6b6d73d6c216473a304fc3dccbdf. 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
The device is indicated for increasing the internal diameter of an artery with the aim of improving blood flow in the following cases: • Patients with symptomatic ischemic heart disease due to “de novo” stenotic and re-stenotic lesions located in arteries with diameters from 2mm to 4.5mm. • Patients with occlusive disease due to acute myocardial infarction located in arteries with diameters from 2mm to 4.5mm
Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer
Brand: iVascular angiolite
M/s.JMD Surgical
Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer
Brand: iVascular angiolite
M/s. B.V Enterprise
Paclitaxel eluting PTA balloon dilatation 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
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
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
Self-expanding peripheral stent system
Brand: iVascular restorer
Thrombus extraction catheter
Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35