K230988 is an FDA 510(k) clearance for the Vial2Bag Advanced® 13mm Admixture Device. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by West Pharma Services Il, Ltd. (Ra'Anana Central, IL). The FDA issued a Cleared decision on December 1, 2023, 239 days after receiving the submission on April 6, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K230988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2023 |
| Decision Date | December 01, 2023 |
| Days to Decision | 239 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 |