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CDSCO UID IMP/MD/2020/000072_01d87fe49075d57590e7277ff1d94578_1c17564d607fe63043c21adb3de80fda

Endovascular Stent Grafts

M/s Cook India Medical Devices Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: Zenith Branch Endovascular Graft Iliac Bifurcation
Registration details
UID
IMP/MD/2020/000072_01d87fe49075d57590e7277ff1d94578_1c17564d607fe63043c21adb3de80fda
Device class
Class C
Brand name
Zenith Branch Endovascular Graft Iliac Bifurcation
License holder
M/s Cook India Medical Devices Pvt. Ltd.
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.
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About this record

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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