Clearance Summary
Disposable High Pressure Injector Syringe received FDA 510(k) clearance under submission number K152906, sponsored by Wuxi Yushou Medical Appliances 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 2016-11-22.
- Submission: K152906
- Applicant / Sponsor: Wuxi Yushou Medical Appliances Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2016-11-22
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.