AMICUS Separator System— 510(k) K200530
Substantially EquivalentFresenius Kabi AG
FDA 510(k) clearance K200530 for AMICUS Separator System, Substantially Equivalent on 2020-09-11. Applicant: Fresenius Kabi AG. Device class: 2.
Clearance details
- Applicant
- Fresenius Kabi AG
- Product code
- Code GKT
- Device class
- Class 2
- Regulation
- 21 CFR 864.9245
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Zurich, IL, US
Recent devices under product code GKT
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view all- K251139 — KabiHelp® Uno; KabiHelp® Advance plus
- K212445 — freeflex+ Transfer Adapter
- K210073 — Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
- K210074 — Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
- K210075 — Vigilant Software Suite Vigilant Master Med
Adverse events under product code GKT
product code GKT- Death
- 167
- Injury
- 301
- Malfunction
- 2,086
- Total
- 2,554
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.