AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
FDA 510(k) clearance K180615 · decided 2018-12-04
Clearance details
- K-number
- K180615
- Device name
- 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
- Decision
- Substantially Equivalent
- Date received
- 2018-03-08
- Decision date
- 2018-12-04
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lake Zurich, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural aphe recall (Z-1254-2023) | Fenwal Inc | 2023-03-15 |
| Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis recall (Z-1255-2023) | Fenwal Inc | 2023-03-15 |