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510(k) K210073

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo by Fresenius Kabi AG — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2022
Date Received
January 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K210075 — Vigilant Software Suite – Vigilant Master Med (March 1, 2022)
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  • K200530 — AMICUS Separator System (September 11, 2020)
  • K192150 — AMICUS Separator System (November 13, 2019)
  • K192368 — CATSmart (September 27, 2019)

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  • K250357 — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (March 11, 2025)
  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Inf (December 23, 2024)