Medical Device Manufacturer · US , Elkton , MD

Terumo Cardiovascular Systems Corporation - FDA 510(k) Cleared Devices

29 submissions · 29 cleared · Since 2002
29
Total
29
Cleared
0
Denied

Terumo Cardiovascular Systems Corporation has 29 FDA 510(k) cleared cardiovascular devices. Based in Elkton, US.

Latest FDA clearance: Apr 2024. Active since 2002.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

29 devices
1–12 of 29
CDI OneView Monitoring System
K234065 · DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass · Cardiovascular
Apr 2024 125d
Terumo Advanced Perfusion System 1
K221895 · DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass · Cardiovascular
Apr 2023 292d
Capiox iCP Centrifugal Pump
K200091 · KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · Cardiovascular
Nov 2021 672d
CDI Blood Parameter Monitoring System 550
K182110 · DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass · Cardiovascular
Nov 2018 88d
Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
K180950 · DTZ Oxygenator, Cardiopulmonary Bypass · Cardiovascular
Jun 2018 72d
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
K172071 · DTZ Oxygenator, Cardiopulmonary Bypass · Cardiovascular
Mar 2018 262d
Advanced Perfusion System 1
K172220 · DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass · Cardiovascular
Aug 2017 24d
Advanced Perfusion System 1
K163531 · DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass · Cardiovascular
Jun 2017 173d
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
K162843 · DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type · Cardiovascular
Nov 2016 37d
VirtuoSaph Plus Endoscopic Vessel Harvesting System
K160206 · GEI Electrosurgical, Cutting & Coagulation & Accessories · General & Plastic Surgery
Apr 2016 84d
Advanced Perfusion System 1
K153376 · DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass · Cardiovascular
Dec 2015 23d
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
K153213 · DTZ Oxygenator, Cardiopulmonary Bypass · Cardiovascular
Dec 2015 28d
Filters
Filter by Specialty
All29 Cardiovascular 27 General & Plastic Surgery 2