VASCULAR INNOVATIONS Hydra Transcatheter Aortic Valve System - HSA Registration DE0509755
Access comprehensive regulatory information for VASCULAR INNOVATIONS Hydra Transcatheter Aortic Valve System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509755 and owned by Vascular Innovations Co., Ltd.. The device was registered on September 09, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Hydra Valve system is indicated for patients with severe symptomatic degenerative aortic stenosis presenting a high predictable operative mortality risk for surgical aortic valve replacement and therefore is referred to transcatheter aortic valve implantation. The decision is based on the clinical judgment of the Heart Team. The Hydra valve transcatheter aortic valve implantation necessitates 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 access vessels with diameters ≥ 5mm for 22 mm & 26mm heart valve and ≥ 5.5mm for 30mm heart valve and anatomical dimensions of the aortic annulus diameter between 18mm to 27mm.