Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1124841

FEI Number

3000204839

Entity Name

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

City/State/Country

ELKTON, MD, US

Establishment Address

125 BLUE BALL RD, ELKTON, MD 21921, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TERUMO CARDIOVASCULAR SYSTEMS CORP. (Owner Number: 1828100)

Owner / Operator Contact Address

6200 Jackson Road, --, Ann Arbor, MI 48103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K810079

PMA Number

N/A

All Registered Proprietary Names

CONDUCER CARDIOPLEGIA SET CDI H/S CUVETTE Tubing PUMP TUBING WITH X-COATING OVERPRESSURE SAFETY VALVE CAPIOX SP PUMP WITH X-COATING Terumo Capiox NX19 Oxygenator with Reservoir Cardiovascular Procedure Kit Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR PUMP TUBING WITH X-COATING CAPIOX CARDIOTOMY RESERVOIR VIRTUOSAPH Capiox iCP Centrifugal Pump TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM CAPIOX CIRCUIT CONNECTORS Stabilizer ADAPTERS WITH X-COATING VirtuoSaph Plus Endoscopic Vessel Harvesting System CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR CIRCUIT TUBINGS WITH X-COATING Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Gas B, Calibration Gas Gas A, Calibration Gas CAPIOX FLEXIBLE VENOUS RESERVOIR SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-01-03
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2008-01-03
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2002-02-25
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2022-11-07
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2008-01-03
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2008-01-03
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2018-08-06
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2018-08-06
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2008-01-03
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2015-12-15
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2015-12-15
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2015-12-15
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2015-12-15
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2008-01-03
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2022-11-07
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2008-01-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-01-05
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2022-01-04
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-06-19
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-06-19
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-06-19
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2014-06-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-04-23
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2014-09-26
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2003-04-08
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2022-11-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-08-23
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2013-03-19
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2022-11-07
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2015-12-15
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2025-08-14
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2008-01-03
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2008-01-03

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 →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K234065	Terumo Cardiovascular Systems Corporation	CDI OneView Monitoring System	2024-04-25
K233702	LivaNova USA, Inc.	SMARxT Tubing and Connectors	2024-08-08
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0011-2011	Maquet Inc.	2	MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1124841. Last updated year: 2026. Please use registration number 1124841 when referencing this establishment in official correspondence.