K190816 is an FDA 510(k) clearance for the Vial Adapter Ø20 mm , Vial Adapter Ø13 mm. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Avenir Performance Europeenne Medical (Apem) (Château-Landon, FR). The FDA issued a Cleared decision on November 19, 2019, 235 days after receiving the submission on March 29, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K190816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2019 |
| Decision Date | November 19, 2019 |
| Days to Decision | 235 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 |