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).
Device ID | K141938 |
510k Number | K141938 |
Device Name: | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) |
Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Applicant | TERUMO BCT, INC.. 10811 WEST COLLINS AVE. Lakewood, CO 80215 |
Contact | Patti Arndt |
Correspondent | Nicholas Wong TERUMO BCT, INC.. 10811 West Collins Ave. Lakewood, CO 80215 |
Product Code | LKN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-17 |
Decision Date | 2015-03-23 |
Summary: | summary |