K233287 is an FDA 510(k) clearance for the Vent 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 July 26, 2024, 301 days after receiving the submission on September 29, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K233287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | July 26, 2024 |
| Days to Decision | 301 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 |