Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000308637

FEI Number

3000308637

Entity Name

FUJI SYSTEMS CORPORATION, Shirakawa Plant

City/State/Country

Nishi Shirakawa Gun Fukushima, JP

Establishment Address

Shirakawa Plant, 200-2 Aza-Ohira, Odakura, Nishigo, Nishi Shirakawa Gun Fukushima 961-8061, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FUJI SYSTEMS CORPORATION (Owner Number: 9052600)

Owner / Operator Contact Address

23-14, HONGO 3-CHOME, BUNKYO-KU, --, TOKYO, JP-13 113-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F Univent Tube 7mm, 7.5mm, 8mm, 8.5mm, 9mm Silbroncho Double Lumen Tube Pediatric Cuffed And Uncuffed Et Tube; Standard Cuffed and Uncuffed Et Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-08-21
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2008-08-26
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2008-07-17
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2008-07-17
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-07-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-11-05
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-11-05
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-08-26

Official Correspondent

No official correspondent registered.

US Agent Details

Gregory Geissinger Business: Geissinger Regulatory Consulting, Inc. Email: greg@geissingerreg.com Phone: (858) 3498839

Related Public Records

Same Entity

FUJI SYSTEMS CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014766734	FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant	Shirakawa Fukushima, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000308637. Last updated year: 2026. Please use registration number 3000308637 when referencing this establishment in official correspondence.