Stent Graft System - India CDSCO Medical Device Registration

Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_2666189da2f9326777135c3a7a614b9d. This device is marketed under the brand name E-vita Thoracic 3G. The license holder is Vibgyor Health Care Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Stent Graft System

UID: IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_2666189da2f9326777135c3a7a614b9d

Brand Name

E-vita Thoracic 3G

License Holder

Vibgyor Health Care Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The E-tegra stent graft system is indicated for the endovascular treatment of infrarenal aortic aneurysms which may also affect the common iliac artery provided the following preconditions are met: • Suitable morphology of the iliac or femoral access vessels • Length of the proximal landing zone in the infrarenal aorta ≥ 15 mm • Angle of the infrarenal aorta distal to the landing zone ≤ 75° • Diameter of the proximal landing zone 19 - 32 mm • Length of the distal landing zone in the common iliac artery ≥ 15 mm • Diameter of the distal landing zone in the common iliac artery 8 - 25 mm • Vascular morphology suitable for the use of a stent graft

Class D

Brand: E-vita Thoracic 3G

Class D