Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009761573

FEI Number

3009761573

Entity Name

KANEKA MEDIX CORPORATION KANAGAWA PLANT

City/State/Country

Ashigara-Kami-gun Kanagawa, JP

Establishment Address

225-1 Aza Deguchi, Yamakita, Yamakita-machi, Ashigara-Kami-gun Kanagawa 2580113, JP

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

K170247

PMA Number

N/A

All Registered Proprietary Names

EDG v4 i-ED COIL Lacriflow CL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2017-04-19

Official Correspondent

No official correspondent registered.

US Agent Details

Audra Bogucki Business: Kaneka Medical America LLC 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
9614654	Kaneka Corporation Osaka Plant	Settsu-shi Osaka, JP
3031550970	KANEKA MEDICAL VIETNAM Co.,Ltd.	Ho Chi Minh, VN

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009761573. Last updated year: 2026. Please use registration number 3009761573 when referencing this establishment in official correspondence.