LKN

FDA Product Code LKN: Separator, Automated, Blood Cell And Plasma, Therapeutic

Leading manufacturers include Terumobct, Inc., Cobe Laboratories, Inc. and Fresenius USA, Inc..

27
Total
27
Cleared
152d
Avg days
1983
Since

FDA 510(k) Cleared Separator, Automated, Blood Cell And Plasma, Therapeutic Devices (Product Code LKN)

27 devices
1–24 of 27
Cleared Nov 13, 2019
AMICUS Separator System
K192150
Fresenius Kabi AG
Gastroenterology & Urology · 96d
Cleared Feb 05, 2019
Spectra Optia Apheresis System
K183081
Terumobct, Inc.
Gastroenterology & Urology · 91d
Cleared Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
K180615
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Nov 01, 2018
Spectra Optia Apheresis System
K181049
Terumobct, Inc.
Gastroenterology & Urology · 195d
Cleared Mar 02, 2018
Spectra Optia Apheresis System
K172590
Terumobct, Inc.
Gastroenterology & Urology · 185d
Cleared Jan 14, 2016
Spectra Optia Apheresis System
K153601
Terumobct, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 11, 2015
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
K151368
Terumo Bct
Gastroenterology & Urology · 113d
Cleared Mar 23, 2015
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
K141938
Terumobct, Inc.
Gastroenterology & Urology · 249d
Cleared Jun 10, 2014
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM
K141019
Fenwal, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 06, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
K132429
Terumobct, Inc.
Gastroenterology & Urology · 123d
Cleared Aug 08, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
K131744
Terumobct, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 22, 2012
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
K111702
Fenwal, Inc.
Gastroenterology & Urology · 279d
Cleared Jan 20, 2012
SPECTRA OPTIA APHERESIS SYSTEM
K113480
Caridianbct, Inc..
Gastroenterology & Urology · 58d
Cleared Nov 19, 2010
SPECTRA OPTIA R APHERESIS SYSTEM
K103090
Caridianbct, Inc..
Gastroenterology & Urology · 31d
Cleared Aug 02, 2007
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
K071079
Gambro Bct, Inc.
Gastroenterology & Urology · 107d
Cleared Sep 05, 2006
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031
K060734
Fresenius Medical Care North America
Gastroenterology & Urology · 169d
Cleared Jun 08, 2005
FRESENIUS ART HEMOADSORPTION SYSTEM
K050273
Fresenius Medical Care North America
Gastroenterology & Urology · 121d
Cleared Jul 31, 1996
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
K961706
Fresenius USA, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 04, 1996
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
K953681
Haemonetics Corp.
Gastroenterology & Urology · 302d
Cleared Mar 22, 1991
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
K900105
Cobe Laboratories, Inc.
Gastroenterology & Urology · 437d
Cleared Nov 02, 1990
FRESENIUS AS 104 CELL SEPARATOR
K895435
Fresenius USA, Inc.
Gastroenterology & Urology · 421d
Cleared Oct 18, 1989
COBE 2991 SUPPLEMENTARY DISPOSABLE SETS
K893962
Cobe Laboratories, Inc.
Gastroenterology & Urology · 138d
Cleared Jan 27, 1988
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
K874607
Organon Teknika Corp.
Gastroenterology & Urology · 79d
Cleared May 16, 1985
GAMBRO PLASMAFILTRATION SYSTEM
K850621
Gambro, Inc.
Gastroenterology & Urology · 90d

About Product Code LKN - Regulatory Context