Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
FDA 510(k) K210073 · Fresenius Kabi AG
510(k) numberK210073
Submission
- Device name
- Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
- Applicant
- Fresenius Kabi AG
Bad Homburg, DE - Received
- January 12, 2021
- Decision date
- March 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
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|---|---|---|
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| K220301 | Volumat LineFPA · Traditional | 06/02/2023SE |
| K212445 | freeflex+ Transfer AdapterLHI · Traditional | 06/01/2022SE |
| K210075 | Vigilant Software Suite Vigilant Master MedPHC · Traditional | 03/01/2022SE |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…FRN · Traditional | 03/01/2022SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | 02/11/2021SE |
| K200530 | AMICUS Separator SystemGKT · Traditional | 09/11/2020SE |
| K192150 | AMICUS Separator SystemLKN · Traditional | 11/13/2019SE |
| K192368 | CATSmartCAC · Special | 09/27/2019SE |
Questions and answers
When was Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo cleared by the FDA?
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo (K210073) received a 510(k) decision of Substantially Equivalent on March 1, 2022, 413 days after the submission was received.
What is the product code of K210073?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.