Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009537152

FEI Number

3009537152

Entity Name

FUJIKURA FIBER OPTICS VIETNAM LTD

City/State/Country

Binh Hoa Ward Ho Chi Minh, VN

Establishment Address

No 9 , Street 6, VSIP,, Binh Hoa Ward Ho Chi Minh 72000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Fujikura Fiber Optics VietNam Ltd (Owner Number: 10044715)

Owner / Operator Contact Address

No 9 , street 6, VSIP, Binh Hoa ward, Thuan An, VN-57 72000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACIST Kodama® Intravascular Ultrasound Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2020-03-31

Official Correspondent

No official correspondent registered.

US Agent Details

Carl Bracken - Business: ACIST Medical Systems, Inc. Email: carl.bracken@acist.com Phone: (952) 2534566

Related Public Records

Same Entity

Fujikura Fiber Optics VietNam 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
K251211	ABBOTT MEDICAL	ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach	2025-05-23
K251231	ABBOTT MEDICAL	ViewFlex X ICE Catheter, Sensor Enabled	2025-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2016	Biosense Webster, Inc.	2	SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

Similar Registrations

Registration Number	Establishment Name	Location
3013844297	DANELIS MEDICAL LIMITED	Rhayader Powys, GB
1058584	Sterigenics US LLC	Charlotte, NC, US
3017894900	Philips Ultrasound LLC	Cambridge, MA, US
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
3019216	Philips Ultrasound LLC	BOTHELL, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009537152. Last updated year: 2026. Please use registration number 3009537152 when referencing this establishment in official correspondence.