510(k) K152906
K152906 is an FDA 510(k) premarket notification submitted by Wuxi Yushou Medical Appliances Co., Ltd. for the device "Disposable High Pressure Injector Syringe". The FDA issued a decision of Substantially Equivalent on Nov 22, 2016. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Wuxi Yushou Medical Appliances Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 22, 2016
- Date Received
- Oct 1, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type
- 510(k)