The following data is part of a premarket notification filed by Youwo (guangzhou) Medical Device Co., Ltd. with the FDA for Sterile High-pressure Angiographic Syringes For Single-use.
| Device ID | K201395 |
| 510k Number | K201395 |
| Device Name: | Sterile High-pressure Angiographic Syringes For Single-use |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Youwo (Guangzhou) Medical Device Co., Ltd. Kaiyuan Avenue, High-Tech Industrial Development Zone Guangzhou, CN 510530 |
| Contact | Meijin Song |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-27 |
| Decision Date | 2020-10-28 |