K201395 is an FDA 510(k) clearance for the Sterile High-pressure Angiographic Syringes for single-use. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Youwo (Guangzhou) Medical Device Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 28, 2020, 154 days after receiving the submission on May 27, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K201395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2020 |
| Decision Date | October 28, 2020 |
| Days to Decision | 154 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 |