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 |