K210073 is an FDA 510(k) clearance for the Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on March 1, 2022, 413 days after receiving the submission on January 12, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K210073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2021 |
| Decision Date | March 01, 2022 |
| Days to Decision | 413 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |