Company ยท US
Terumobct, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2019. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 2019 | K183081 | Spectra Optia Apheresis System Terumobct, Inc. | LKN |
| Nov 1, 2018 | K181049 | Spectra Optia Apheresis System Terumobct, Inc. | LKN |
| Mar 2, 2018 | K172590 | Spectra Optia Apheresis System Terumobct, Inc. | LKN |
| Feb 16, 2017 | K162365 | T-Cuff Terumobct, Inc. | KCY |
| Jan 14, 2016 | K153601 | Spectra Optia Apheresis System Terumobct, Inc. | LKN |
| Mar 23, 2015 | K141938 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) Terumobct, Inc. | LKN |
| Dec 6, 2013 | K132429 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET Terumobct, Inc. | LKN |
| Aug 8, 2013 | K131744 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE Terumobct, Inc. | LKN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||