Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009500972

FEI Number

3009500972

Entity Name

TERUMO CLINICAL SUPPLY CO., LTD.

City/State/Country

Kakamigahara Gifu, JP

Establishment Address

3 Kawashima-Takehaya-machi,, Kakamigahara Gifu 501-6024, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Terumo Clinical Supply Co., Ltd. (Owner Number: 10039657)

Owner / Operator Contact Address

3 Kawashima-Takehaya-machi,, Kakamigahara,Gifu, JP-NOTA 501-6024, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112382

PMA Number

N/A

All Registered Proprietary Names

Progreat Lambda Progreat Lambda Peripheral Microcatheter Terumo PriorityOne AC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2021-12-22
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-12-22
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2012-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

Dina Justice Business: TERUMO Medical Corp Email: dina.justice@terumomedical.com Phone: (410) 3927226

Related Public Records

Same Entity

Terumo Clinical Supply Co., Ltd.

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
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009500972. Last updated year: 2026. Please use registration number 3009500972 when referencing this establishment in official correspondence.