Argon OPTION and OPTION ELITE Retrievable Vena Cava Filter System - HSA Registration DE0018396
Access comprehensive regulatory information for Argon OPTION and OPTION ELITE Retrievable Vena Cava Filter 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 DE0018396 and owned by Argon Medical Devices, Inc.. The device was registered on July 21, 2016.
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 device is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in thromboembolic disease, Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The Option Filter may be removed in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.