ClearanceBrief
Company ยท US

CaridianBCT, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2012. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic4
KZEInjector, Fluid, Non-Electrically Powered1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 20, 2012K113480SPECTRA OPTIA APHERESIS SYSTEM
Caridianbct, Inc..
LKN
Nov 19, 2010K103090SPECTRA OPTIA R APHERESIS SYSTEM
Caridianbct, Inc..
LKN

Latest recalls

DateFirm and productCodeLinked 510(k)
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 11, 2012CaridianBCT, Inc.
Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.
Terminated		 KZEK090003
May 9, 2012CaridianBCT, Inc.
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
Terminated		 LKNK071079
K103090
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