Endovascular Stent Grafts - India CDSCO Medical Device Registration

Endovascular Stent Grafts is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000072_01d87fe49075d57590e7277ff1d94578_1c17564d607fe63043c21adb3de80fda. This device is marketed under the brand name Zenith Branch Endovascular Graft Iliac Bifurcation. The license holder is M/s Cook India Medical Devices Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Endovascular Stent Grafts

UID: IMP/MD/2020/000072_01d87fe49075d57590e7277ff1d94578_1c17564d607fe63043c21adb3de80fda

Brand Name

Zenith Branch Endovascular Graft Iliac Bifurcation

License Holder

M/s Cook India Medical Devices Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Zenith® Branch Endovascular Graft-Iliac Bifurcation with the H&L-B One-Shot? Introduction System is indicated for the endovascular treatment of patients with an aortoiliac or iliac aneurysm, an insufficient distal sealing site within the common iliac artery, and having morphology suitable for endovascular repair, including: ? Adequate iliac/femoral access compatible with a 20 French (Zenith Branch Endovascular Graft Iliac Bifurcation) introduction system, ? Non-aneurysmal external iliac artery fixation segment distal to the aneurysm: - With a length of at least 20 mm, - With a diameter measured outer wall to outer wall of no greater than 11 mm and no less than 8 mm. ? Non-aneurysmal internal iliac artery segment distal to the aneurysm: - With a length of at least 10 mm (Zenith Branch Endovascular Graft Iliac Bifurcation) - With a diameter acceptable for proper sealing.