K222718 is an FDA 510(k) clearance for the Vial Adapter. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 10, 2023, 183 days after receiving the submission on September 8, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K222718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2022 |
| Decision Date | March 10, 2023 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |