ClearanceBrief
Product code LKN ยท Class U

Separator, Automated, Blood Cell And Plasma, Therapeutic

0510(k)s in 12 months (27 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in LKN

Company510(k)sRecalls
Fenwal, Inc.25
Terumobct, Inc.70
Caridianbct, Inc..22
Fresenius Kabi AG22
Caridian BCT, Incorporated02
Cobe Laboratories, Inc.20
Fresenius USA, Inc.20
Fresenius Medical Care North America20
Gambro Bct, Inc.11
Apheresis Technologies, Inc.10
DateFirm and productCodeLinked 510(k)
Mar 15, 2023Fenwal Inc
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Open, Classified		 LKNK180615
Mar 15, 2023Fenwal Inc
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Open, Classified		 LKNK180615
Feb 25, 2021Fenwal Inc
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Terminated		 LKNK180615
Feb 25, 2021Fenwal Inc
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Terminated		 LKNK180615
Jun 8, 2013Fenwal Inc
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyr
Terminated		 LKNK111702
May 30, 2012CaridianBCT, Inc.
Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in
Terminated		 LKNK103090
May 9, 2012CaridianBCT, Inc.
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
Terminated		 LKNK071079
K103090
Nov 16, 2011Caridian BCT, Incorporated
Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
Terminated		 LKNK071079
K103090
Jun 28, 2011Caridian BCT, Incorporated
Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications
Terminated		 LKNK071079
K103090
May 16, 2011Fresenius Kabi, LLC
The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used f
Terminated		 LKNK961706
Dec 16, 2010Fresenius Kabi, LLC
Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". Intended use: The Fresenius RBC red blood c
Terminated		 LKNNone listed
Oct 31, 2007Gambro BCT, Inc.
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
Terminated		 LKNK071079

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