Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1118880

FEI Number

1118880

Entity Name

TERUMO MEDICAL CORP.

City/State/Country

ELKTON, MD, US

Establishment Address

950 ELKTON BLVD., ELKTON, MD 21921, US

Establishment Type(s)

Manufacture Device in the United States for Export Only,Manufacture Medical Device

Owner / Operator

TERUMO MEDICAL CORP. (Owner Number: 9003933)

Owner / Operator Contact Address

265 Davidson Avenue, Ste. 320, Somerset, NJ 08873, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K003424

PMA Number

N/A

All Registered Proprietary Names

CDI Shunt Sensor Holder, Suture Holder Assistant Attachment with StableSoft Technology Assistant Flex Attachment with StableSoft Technology Stabilizer II with StableSoft Technology Glidesheath Glidesheath Slender MedAmicus Coaxial Introducer Angio-Seal VIP Vascular Closure Device Angio-Seal Glidewire GT, Glidewire Gold Radifocus Glidewire, Mandrel Guidewire Assembly Glidesheath Slender Tibial Pedal Kit Radifocus Introducer II with R/O Marker Pinnacle R/O II TR Band Radial Compression Device R2P NaviCross TR BAND® Radial Compression Device; TR Band Manan GWI Guide Wire Introducer Pinnacle R/O II HiFlo Nagare Bi-Directional Steerable Sheath Radifocus Introducer II with R/O Marker Pinnacle R/O II

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	2009-12-01
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2026-02-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-12-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-05-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	1996-04-15
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2017-01-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2006-01-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-12-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-11-07
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2022-01-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-07-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-12-02
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2006-01-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-08-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TERUMO MEDICAL 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
3013394970	Terumo Puerto Rico LLC	Caguas, PR, US
2243441	TERUMO MEDICAL CORP.	Somerset, NJ, US
3008307705	Terumo Medical Canada, Inc.	Vaughan Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K234065	Terumo Cardiovascular Systems Corporation	CDI OneView Monitoring System	2024-04-25
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17

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-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

Registration Number	Establishment Name	Location
1828100	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION	ANN ARBOR, MI, US
3006073153	SPECTRUM MEDICAL LTD	GLOUCESTER Gloucestershire, GB
1124841	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION	ELKTON, MD, US
9611109	LivaNova Deutschland GmbH	MUNCHEN Bavaria, DE
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1118880. Last updated year: 2026. Please use registration number 1118880 when referencing this establishment in official correspondence.