Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014758755

FEI Number

3014758755

Entity Name

KANEKA AMERICAS HOLDING INC

City/State/Country

Newark, CA, US

Establishment Address

7979 Gateway Blvd, Newark, CA 94560, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

KANEKA AMERICAS HOLDING INC (Owner Number: 10095053)

Owner / Operator Contact Address

7979 Gateway Blvd, Newark, CA 94560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251668

PMA Number

N/A

All Registered Proprietary Names

Surfrider 13 Microcatheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-01-19
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2026-01-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KANEKA AMERICAS HOLDING INC

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
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3026567963	ENDOVASCULAR ENGINEERING, INC.	Menlo Park, CA, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3019525998	VASCUPATENT MEDICAL (SHENZHEN) CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014758755. Last updated year: 2026. Please use registration number 3014758755 when referencing this establishment in official correspondence.