AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
FDA 510(k) K180615 · Fresenius Kabi USA,Llc
510(k) numberK180615
Submission
- 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
Lake Zurich, IL, US - Received
- March 8, 2018
- Decision date
- December 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device class
- Unclassified
Other 510(k)s with product code LKN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192150 | AMICUS Separator SystemLKN · Traditional | Fresenius Kabi AG | 11/13/2019SE |
| K183081 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 02/05/2019SE |
| K181049 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 11/01/2018SE |
| K172590 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 03/02/2018SE |
| K153601 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 01/14/2016SE |
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…LKN · Traditional | Terumo Bct | 09/11/2015SE |
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)LKN · Traditional | Terumobct, Inc. | 03/23/2015SE |
| K141019 | Amicus Separator System/ Amicus Seperator System;RefurbishedLKN · Traditional | Fenwal, Inc. | 06/10/2014SE |
| K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…LKN · Traditional | Terumobct, Inc. | 12/06/2013SE |
| K131744 | Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…LKN · Traditional | Terumobct, Inc. | 08/08/2013SE |
More from Terumobct, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K162462 | AMICUS Separator System, AMICUS Separator System; RefurbishedGKT · Traditional | 11/23/2016SE |
Questions and answers
When was AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter cleared by the FDA?
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (K180615) received a 510(k) decision of Substantially Equivalent on December 4, 2018, 271 days after the submission was received.
What is the product code of K180615?
The FDA product code is LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic, a Unclassified device.