K190149 is an FDA 510(k) clearance for the Vial Adapter Ø20 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 October 15, 2019, 259 days after receiving the submission on January 29, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K190149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2019 |
| Decision Date | October 15, 2019 |
| Days to Decision | 259 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 |