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/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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class D

Endovascular Stent Grafts

UID: IMP/MD/2018/000191_01d87fe49075d57590e7277ff1d94578_b906e6b8d4f69008381e978345ba9aef

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.

Device Class

Class D

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)