Medical Device Manufacturer · US , Lakewood , CO

Terumobct, Inc.

8 submissions · 8 cleared · Since 2013
8
Total
8
Cleared
0
Denied

Terumobct, Inc. — FDA 510(k) Submissions

Terumobct, Inc. has submitted 8 FDA 510(k) premarket notifications since 2013, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Separator, Automated, Blood Cell And Plasma, Therapeutic, Tourniquet, Pneumatic . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
Spectra Optia Apheresis System
K183081 · LKN Separator, Automated,... · Gastroenterology & Urology
Feb 2019 91d
Spectra Optia Apheresis System
K181049 · LKN Separator, Automated,... · Gastroenterology & Urology
Nov 2018 195d
Spectra Optia Apheresis System
K172590 · LKN Separator, Automated,... · Gastroenterology & Urology
Mar 2018 185d
T-Cuff
K162365 · KCY Tourniquet, Pneumatic · General & Plastic Surgery
Feb 2017 177d
Spectra Optia Apheresis System
K153601 · LKN Separator, Automated,... · Gastroenterology & Urology
Jan 2016 29d
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
K141938 · LKN Separator, Automated,... · Gastroenterology & Urology
Mar 2015 249d
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
K132429 · LKN Separator, Automated,... · Gastroenterology & Urology
Dec 2013 123d
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
K131744 · LKN Separator, Automated,... · Gastroenterology & Urology
Aug 2013 56d
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