FDA 510(k) Applications Submitted by Nicholas Wong
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K181049 |
04/20/2018 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
| K151368 |
05/21/2015 |
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter |
TERUMO BCT |
| K211579 |
05/21/2021 |
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) |
Bolder Surgical, LLC. |
| K202114 |
07/30/2020 |
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 |
Bolder Surgical, LLC |
| K172590 |
08/29/2017 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
| K203183 |
10/27/2020 |
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) |
Bolder Surgical, LLC |
| K183081 |
11/06/2018 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
| K203640 |
12/14/2020 |
CoolSeal Reveal |
Bolder Surgical, LLC |
| K153601 |
12/16/2015 |
Spectra Optia Apheresis System |
Terumo BCT, Inc |
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