LKN · Separator, Automated, Blood Cell And Plasma, Therapeutic
· Class U
Overview
| Product Code | LKN |
|---|---|
| Device Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192150 | AMICUS Separator System | Fresenius Kabi AG | Nov 13, 2019 | SESE |
| K183081 | Spectra Optia Apheresis System | Terumobct, Inc. | Feb 5, 2019 | SESE |
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | Fresenius Kabi USA,Llc | Dec 4, 2018 | SESE |
| K181049 | Spectra Optia Apheresis System | Terumobct, Inc. | Nov 1, 2018 | SESE |
| K172590 | Spectra Optia Apheresis System | Terumobct, Inc. | Mar 2, 2018 | SESE |
| K153601 | Spectra Optia Apheresis System | Terumobct, Inc. | Jan 14, 2016 | SESE |
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter | Terumo Bct | Sep 11, 2015 | SESE |
| K141938 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) | Terumobct, Inc. | Mar 23, 2015 | SESE |
| K141019 | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED | Fenwal, Inc. | Jun 10, 2014 | SESE |
| K132429 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET | Terumobct, Inc. | Dec 6, 2013 | SESE |
| K131744 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE | Terumobct, Inc. | Aug 8, 2013 | SESE |
| K111702 | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE | Fenwal, Inc. | Mar 22, 2012 | SESE |
| K113480 | SPECTRA OPTIA APHERESIS SYSTEM | Caridianbct, Inc.. | Jan 20, 2012 | SESE |
| K103090 | SPECTRA OPTIA R APHERESIS SYSTEM | Caridianbct, Inc.. | Nov 19, 2010 | SESE |
| K071079 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 | Gambro Bct, Inc. | Aug 2, 2007 | SESE |
| K060734 | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) | Fresenius Medical Care North America | Sep 5, 2006 | SESE |
| K050273 | FRESENIUS ART HEMOADSORPTION SYSTEM | Fresenius Medical Care North America | Jun 8, 2005 | SESE |
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | Fresenius USA, Inc. | Jul 31, 1996 | SESE |
| K953681 | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | Haemonetics Corp. | Jun 4, 1996 | SESE |
| K926409 | PLASMA DISCARD BAGS | Apheresis Technologies, Inc. | Mar 2, 1993 | SESE |
Top Applicants
- Terumobct, Inc. — 7 clearances
- Caridianbct, Inc.. — 2 clearances
- Cobe Laboratories, Inc. — 2 clearances
- Fenwal, Inc. — 2 clearances
- Fresenius Medical Care North America — 2 clearances
