TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

FDA Device Registration & Listing · ANN ARBOR, MI, US · Registration 1828100

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1828100
FEI Number
1828100
Entity Name
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
City/State/Country
ANN ARBOR, MI, US
Establishment Address
6200 Jackson Road, ANN ARBOR, MI 48103, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Terumo Cardiovascular Systems Corp. (Owner Number: 10039199)
Owner / Operator Contact Address
6200 Jackson Road, Ann Arbor, MI 48103, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K953904
PMA Number
N/A

All Registered Proprietary Names

CDI OneView Monitoring System Advanced Perfusion System 1 CDI (TM) SYSTEM 100 MONITORING SYSTEM Terumo Advanced Perfusion System 1 Roller Pump for the Terumo Advanced Perfusion System 1 Pump Speed Controller CDI BLOOD PARAMETER MONITORING SYSTEM 500 ADVANCED PERFUSION SYSTEM 1 TEMPERATURE CONTROL & MONITOR Pump SAMS 8000 Pressure Tubing SARNS 8000 MODULAR PERFUSION SYSTEM LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 CDI BLOOD PARAMETER MONITORING SYSTEM 500 Blade Advanced Perfusion System 1 SARNS CDI Blood Parameter Monitoring System 550 SARNS Flow Sensor ADVANCED PERFUSION SYSTEM 1 SARNS DELPHIN BASE ADAPTER WITH BATTERY HLM SARNS 9000 UNIVERSAL ROLLER PUMP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2024-05-01
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2016-02-04
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2011-12-16
DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4410 2011-12-16
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2023-05-23
DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type Cardiovascular Class 2 870.4370 2017-02-15
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2014-06-02
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2014-08-14
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2014-07-11
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2016-05-25
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2011-12-16
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2011-12-16
DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type Cardiovascular Class 2 870.4370 2011-12-16
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2011-12-16
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2011-12-16
DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass Cardiovascular Class 2 870.4340 2011-12-16
KRL Detector, Bubble, Cardiopulmonary Bypass Cardiovascular Class 2 870.4205 2011-12-16
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2011-12-16
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2011-12-16
DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type Cardiovascular Class 2 870.4370 2011-12-16
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2011-12-16
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2011-12-16
DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type Cardiovascular Class 2 870.4370 2013-12-10
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2013-01-21
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2011-12-16
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2017-06-12
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2011-12-16
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2018-11-07
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2011-12-16
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2011-12-16
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2011-12-16
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2020-02-13
DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type Cardiovascular Class 2 870.4370 2011-12-16

Official Correspondent

Lisa Hessabi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Terumo Cardiovascular Systems Corp.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017987980 Terumo Cardiovascular Costa Rica LLC Zona Franca La Lima Cartago, CR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K234065 Terumo Cardiovascular Systems Corporation CDI OneView Monitoring System 2024-04-25
K822071 Gambro, Inc. PUMP MODULES PMO LO-110-PMD 10-210 1982-08-24
K001520 Alpha Omega, Inc. ALPHA OMEGA DUAL COOLER-HEATER 2000-11-22
K190624 Philips Medizin Systeme Boeblingen GmbH EarlyVue VS30 2019-10-27
K771977 Instrumentation Laboratory CO CARDIAC OUTPUT COMPUTER MODEL 701 1978-01-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2011 Terumo Cardiovascular Systems Corporation 2
Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI
Z-0001-2017 Terumo Cardiovascular Systems Corporation 2
CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
Z-0035-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Z-0036-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Z-0037-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1828100. Last updated year: 2026. Please use registration number 1828100 when referencing this establishment in official correspondence.
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