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. Device class: Unclassified.
Clearance details
- Applicant
- Fresenius Kabi USA,Llc
- Product code
- Code LKN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Zurich, IL, US
Recent devices under product code LKN
view allMore clearances from Fresenius Kabi USA,Llc
view allAdverse 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 →
Recalls naming K180615
K-number listed on FDA's recall record- Z-1254-2023 — Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
- Z-1255-2023 — Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Z-1344-2021 — Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
- Z-1345-2021 — Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180615.
Data sourced from openFDA. This site is unofficial and independent of the FDA.