AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter— 510(k) K180615
Substantially EquivalentFresenius Kabi USA,Llc
FDA 510(k) clearance K180615 for AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter, Substantially Equivalent on 2018-12-04. Applicant: Fresenius Kabi USA,Llc.
Clearance details
- Applicant
- Fresenius Kabi USA,Llc
- Product code
- Code LKN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Zurich, IL, US
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.