Singapore HSA registration DE0018396
Argon OPTION and OPTION ELITE Retrievable Vena Cava Filter System
Singapore·CLASS D·Argon Medical Devices, Inc.·Registered July 21, 2016Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0018396
- Registration Date
- July 21, 2016
- Change Notification Approval Date
- October 29, 2024
- Retention Due Date
- July 20, 2025
Product description
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.
Product Owner
- Short Name
- Argon Medical Devices, Inc.
- Address
- 1445 Flat Creek Road, Athens, Texas 75751, UNITED STATES
Registrant
- Address
- 8 KENSINGTON PARK DRIVE, KENSINGTON PARK, #01-01, SINGAPORE 557323
Importer
- Address
- 198 YISHUN AVENUE 7, SINGAPORE 768926 10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model information
- Model Name(s)
- OPTION Vena Cava Filter System OPTION ELITE Vena Cava Filter System OPTION ELITE 100cm Vena Cava Filter System
- Model Identifier(s)
- 352506070 352506070E 352506100E
About this record
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.
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