SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)

Separator, Automated, Blood Cell And Plasma, Therapeutic

TERUMO BCT, INC..

The following data is part of a premarket notification filed by Terumo Bct, Inc.. with the FDA for Spectra Optia Apheresis System, Spectra Optia Exchange Set (disposable Blood Tubing Set).

Pre-market Notification Details

Device IDK141938
510k NumberK141938
Device Name:SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant TERUMO BCT, INC.. 10811 WEST COLLINS AVE. Lakewood,  CO  80215
ContactPatti Arndt
CorrespondentNicholas Wong
TERUMO BCT, INC.. 10811 West Collins Ave. Lakewood,  CO  80215
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-17
Decision Date2015-03-23
Summary:summary

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