Clearance Summary
Venera 508 Deep Vein Thrombosis (DVT) Prevention System received FDA 510(k) clearance under submission number K180389, sponsored by Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-06-29.
- Submission: K180389
- Applicant / Sponsor: Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2018-06-29
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.