510(k) K180615 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
| Applicant | Fresenius Kabi USA,Llc, Lake Zurich IL, US |
| Decision | Substantially Equivalent, Dec 4, 2018 |
| Received | Mar 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2023 | Fenwal Inc Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform Open, Classified |
LKN | None listed |
| Mar 15, 2023 | Fenwal Inc Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform Open, Classified |
LKN | None listed |
| Feb 25, 2021 | Fenwal Inc Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells. Terminated |
LKN | None listed |
| Feb 25, 2021 | Fenwal Inc Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells. Terminated |
LKN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.