AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter

Separator, Automated, Blood Cell And Plasma, Therapeutic

Fresenius Kabi USA LLC

The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc with the FDA for Amicus Separator System, Amicus Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter.

Pre-market Notification Details

Device IDK180615
510k NumberK180615
Device Name:AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant Fresenius Kabi USA LLC Three Corporate Drive Lake Zurich,  IL  60047
ContactKim Forch
CorrespondentKim Forch
Fresenius Kabi USA LLC Three Corporate Drive Lake Zurich,  IL  60047
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-08
Decision Date2018-12-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04086000101950 K180615 000
04052682031724 K180615 000

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