Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031550970

FEI Number

3031550970

Entity Name

KANEKA MEDICAL VIETNAM Co.,Ltd.

City/State/Country

Ho Chi Minh, VN

Establishment Address

35 VSIP Street 6, Vietnam - Singapore Industrial Park, An Phu Word, Ho Chi Minh NA, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KANEKA CORP. (Owner Number: 9005249)

Owner / Operator Contact Address

2-3-18, Nakanoshima, Kita-ku, Osaka, JP-27 530-8288, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210638

PMA Number

N/A

All Registered Proprietary Names

OTW Takeru RX Takeru EDG v4 i-ED COIL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2018-03-19
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2017-04-09
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2021-03-28
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2021-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Audra Bogucki Email: Audra.bogucki@kaneka.com Phone: (917) 6289870

Related Public Records

Same Entity

KANEKA 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
3031408734	KANEKA CORPORATION TOMATOH PLANT	Tomakomai-city Hokkaido, JP
3009761573	KANEKA MEDIX CORPORATION KANAGAWA PLANT	Ashigara-Kami-gun Kanagawa, JP
9614654	Kaneka Corporation Osaka Plant	Settsu-shi Osaka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951256	Target Therapeutics	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	1995-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

Similar Registrations

Registration Number	Establishment Name	Location
9614654	Kaneka Corporation Osaka Plant	Settsu-shi Osaka, JP
3010273872	Synergy Health AST, SRL	Alajuela, CR
3007836437	HOSMED INC.	Doral, FL, US
9681260	Boston Scientific Limited	GALWAY, IE
2124215	Boston Scientific Corporation	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031550970. Last updated year: 2026. Please use registration number 3031550970 when referencing this establishment in official correspondence.