FDA.reportPublic FDA data

510(k) K141938

Device
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
Applicant
TERUMO BCT, INC..
510(k) number
K141938
Product code
LKN  
Decision
Substantially Equivalent (SESE)
Decision date
2015-03-23
Date received
2014-07-17
Regulation
510(k) Premarket Notification
Classification name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Gastroenterology/Urology
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PATTI ARNDT
Address
10811 W. Collins Ave. Lakewood CO US 80215 80215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192150AMICUS Separator SystemFresenius Kabi AG2019-11-13
K183081Spectra Optia Apheresis SystemTerumobct, Inc.2019-02-05
K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,Llc2018-12-04
K181049Spectra Optia Apheresis SystemTerumobct, Inc.2018-11-01
K172590Spectra Optia Apheresis SystemTerumobct, Inc.2018-03-02
K153601Spectra Optia Apheresis SystemTerumobct, Inc.2016-01-14
K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection AdapterTerumo Bct2015-09-11
K141019AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHEDFenwal, Inc.2014-06-10
K132429SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SETTerumobct, Inc.2013-12-06
K131744SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARETerumobct, Inc.2013-08-08
K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPEFenwal, Inc.2012-03-22
K113480SPECTRA OPTIA APHERESIS SYSTEMCaridianbct, Inc..2012-01-20
K103090SPECTRA OPTIA R APHERESIS SYSTEMCaridianbct, Inc..2010-11-19
K071079SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200Gambro Bct, Inc.2007-08-02
K060734FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)Fresenius Medical Care North America2006-09-05

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases