VASCULAR INNOVATIONS COCOON VSD Occluder and Delivery System - HSA Registration DE0509069
Access comprehensive regulatory information for VASCULAR INNOVATIONS COCOON VSD Occluder and Delivery 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 DE0509069 and owned by Vascular Innovations Co., Ltd.. The device was registered on March 15, 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 Cocoon VSD Occluder is a percutaneous, transcatheter ventricular septal defect (VSD) closure device intended for the occlusion of hemodynamically significant ventricular septal defects. Indications - Patients who have evidence of left ventricular and/or left atrial enlargement or Qp/Qs greater than 1.5 as shown by TTE, cardiomegaly and increased pulmonary vasculature on chest x-ray or diastolic murmur at apex. - Patients with ventricular septal defect size as determined by TEE is between 2 and 10 mm.