The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Vented Vial Transfer Pin.
| Device ID | K221406 |
| 510k Number | K221406 |
| Device Name: | Vented Vial Transfer Pin |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Jianwei Pan Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20197344001696 | K221406 | 000 |