FDA 510(k)
FDA unclassified
Substantially Equivalent
🇩🇪 Germany
AMICUS Separator System
K Number: K192150
·
Decision Nov 13, 2019
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
12
Review Days
96
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Basic Information
- Device Name
- AMICUS Separator System
- K Number
- K192150
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Kabi AG
- Date Received
- August 9, 2019
- Decision Date
- November 13, 2019
- Product Code
- LKN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKN), ordered by most recent decision date.
Spectra Optia Apheresis System
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AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
FDA 510(k)
FDA Unclassified
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
FDA 510(k)
FDA Unclassified
·Unknown
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|---|---|---|---|
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| K210075 | Vigilant Software Suite Vigilant Master Med | Mar 1, 2022 | Substantially Equivalent |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Feb 11, 2021 | Substantially Equivalent |
| K200530 | AMICUS Separator System | Sep 11, 2020 | Substantially Equivalent |
| K192368 | CATSmart | Sep 27, 2019 | Substantially Equivalent |
| K180831 | CATSmart | Dec 10, 2018 | Substantially Equivalent |
| K160735 | CATSmart | Sep 16, 2016 | Substantially Equivalent |