The following data is part of a premarket notification filed by Shinva Ande Healthcare Apparatus Co., Ltd. with the FDA for Closed System Transfer Device.
| Device ID | K201460 |
| 510k Number | K201460 |
| Device Name: | Closed System Transfer Device |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road, New & Hi-Tech Zone Zibo, CN 255086 |
| Contact | XiaoLei Tian |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-02 |
| Decision Date | 2022-11-23 |