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 |