Clearance Summary
Option ELITE Vena Cava Filter System (352506070E 352506100E) received FDA 510(k) clearance under submission number K242612, sponsored by Argon Medical Devices, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-09-10.
- Submission: K242612
- Applicant / Sponsor: Argon Medical Devices, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3375
- Decision date: 2024-09-10
Classification & Regulation
This clearance is catalogued under FDA product code DTK and 21 CFR 870.3375, within the Cardiovascular review panel as a Class II device.