AMICUS Separator System— 510(k) K192150
Substantially EquivalentFresenius Kabi AG
FDA 510(k) clearance K192150 for AMICUS Separator System, Substantially Equivalent on 2019-11-13. Applicant: Fresenius Kabi AG. Device class: Unclassified.
Clearance details
- Applicant
- Fresenius Kabi AG
- Product code
- Code LKN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bad Homburg, DE
Recent devices under product code LKN
view all- K183081 — Spectra Optia Apheresis System
- K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
- K181049 — Spectra Optia Apheresis System
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- K153601 — Spectra Optia Apheresis System
More clearances from Fresenius Kabi AG
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 LKN
product code LKN- Death
- 50
- Injury
- 314
- Total
- 364
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.