Transcatheter Aortic Valve
- UID
- IMP/MD/2020/000025_48fe5c68e995038f500d4fd410b1353a_2c437b15ca39acb13dea0a2c8b7b872d
- Device class
- Class D
- Brand name
- Hydra Aortic Valve and Delivery System
- License holder
- Vascular Concepts Limited
- Approving authority
- CDSCO
- Product information
- The Hydra Valve System is designed for use in high surgical risk patients with severe aortic stenosis. The Hydra Valve System is indicated for patients with severe symptomatic native aortic valve stenosis necessitating valve replacement of the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve and presenting with femoral or subclavian/axillary access vessels with diameters ≥6mm and anatomical dimensions of the aortic annulus diameter between 18mm to 27mm.
Transcatheter Aortic Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000025_48fe5c68e995038f500d4fd410b1353a_2c437b15ca39acb13dea0a2c8b7b872d. This device is marketed under the brand name Hydra Aortic Valve and Delivery System. The license holder is Vascular Concepts Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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