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CDSCO UID IMP/MD/2018/000191_01d87fe49075d57590e7277ff1d94578_b906e6b8d4f69008381e978345ba9aef

Endovascular Stent Grafts

M/s Cook India Medical Devices Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: Torcon NB® Advantage Catheter, Royal Flush® Plus High Flow Catheter & Torcon NB® Advantage Catheter
Registration details
UID
IMP/MD/2018/000191_01d87fe49075d57590e7277ff1d94578_b906e6b8d4f69008381e978345ba9aef
Device class
Class D
Brand name
Torcon NB® Advantage Catheter, Royal Flush® Plus High Flow Catheter & Torcon NB® Advantage Catheter
License holder
M/s Cook India Medical Devices Pvt. Ltd.
Approving authority
CDSCO
Product information
The Zenith Flex AAA Endovascular Graft with the Z-Trak Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: • Adequate iliac/femoral access compatible with the required introduction systems, • Non-aneurysmal infrarenal aortic segment (Torcon NB® Advantage Catheter, Royal Flush® Plus High Flow Catheter & Torcon NB® Advantage Catheter) proximal to the aneurysm: • with a length of at least 15 mm, • with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm, • with an angle less than 60 degrees relative to the long axis of the aneurysm, and • with an angle less than 45 degrees relative to the axis of the suprarenal aorta. • Iliac artery distal fixation site greater than 10 mm in length and 7.5-20 mm in diameter (Torcon NB® Advantage Catheter, Royal Flush® Plus High Flow Catheter & Torcon NB® Advantage Catheter)
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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/2018/000191_01d87fe49075d57590e7277ff1d94578_b906e6b8d4f69008381e978345ba9aef. This device is marketed under the brand name Torcon NB® Advantage Catheter, Royal Flush® Plus High Flow Catheter & Torcon NB® Advantage Catheter. The license holder is M/s Cook India Medical Devices Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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