FDA 510(k) Applications for Medical Device Product Code "LKN"
(Separator, Automated, Blood Cell And Plasma, Therapeutic)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K113480 |
CARIDIANBCT, INC. |
SPECTRA OPTIA APHERESIS SYSTEM |
01/20/2012 |
K103090 |
CARIDIANBCT, INC. |
SPECTRA OPTIA R APHERESIS SYSTEM |
11/19/2010 |
K111702 |
FENWAL, INC. |
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE |
03/22/2012 |
K141019 |
FENWAL, INC. |
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED |
06/10/2014 |
K192150 |
Fresenius Kabi AG |
AMICUS Separator System |
11/13/2019 |
K180615 |
Fresenius Kabi USA LLC |
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter |
12/04/2018 |
K050273 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS ART HEMOADSORPTION SYSTEM |
06/08/2005 |
K060734 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) |
09/05/2006 |
K961706 |
FRESENIUS USA, INC. |
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR |
07/31/1996 |
K071079 |
GAMBRO BCT, INC. |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 |
08/02/2007 |
K953681 |
HAEMONETICS CORP. |
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET |
06/04/1996 |
K151368 |
TERUMO BCT |
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter |
09/11/2015 |
K153601 |
Terumo BCT, Inc |
Spectra Optia Apheresis System |
01/14/2016 |
K172590 |
Terumo BCT, Inc. |
Spectra Optia Apheresis System |
03/02/2018 |
K181049 |
Terumo BCT, Inc. |
Spectra Optia Apheresis System |
11/01/2018 |
K183081 |
Terumo BCT, Inc. |
Spectra Optia Apheresis System |
02/05/2019 |
K141938 |
TERUMO BCT, INC.. |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) |
03/23/2015 |
K131744 |
TERUMO BCT, INC.. |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE |
08/08/2013 |
K132429 |
TERUMO BCT, INC.. |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET |
12/06/2013 |
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