K152906 is an FDA 510(k) clearance for the Disposable High Pressure Injector Syringe. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Wuxi Yushou Medical Appliances Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on November 22, 2016, 418 days after receiving the submission on October 1, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K152906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2015 |
| Decision Date | November 22, 2016 |
| Days to Decision | 418 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |