K232987 is an FDA 510(k) clearance for the FlowArt Valve for Vial Access. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Asset Medikal Tasarim Sanayi VE Ticaret A.S. (Istanbul, TR). The FDA issued a Cleared decision on June 26, 2024, 278 days after receiving the submission on September 22, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K232987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2023 |
| Decision Date | June 26, 2024 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |