Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004718255

FEI Number

3004718255

Entity Name

ASAHI INTECC USA, INC.

City/State/Country

Tustin, CA, US

Establishment Address

3002 Dow Ave Suite 212, Tustin, CA 92780, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ASAHI INTECC CO., LTD. (Owner Number: 9051916)

Owner / Operator Contact Address

3-100 Akatsuki-cho, --, Seto, JP-23 489-0071, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192782

PMA Number

N/A

All Registered Proprietary Names

ASAHI CROSSWALK Peripheral Support Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASAHI INTECC CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016119728	Toyoflex Cebu Corporation	Lapu-Lapu Cebu, PH
3003780911	ASAHI INTECC (THAILAND) CO., LTD.	Amphur Muang Pathumthani Pathum Thani, TH
3009121749	ASAHI INTECC HANOI CO., LTD.	Hanoi Ha Noi, VN
3003775027	ASAHI INTECC CO., LTD.	SETO Aichi, 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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3010370269	STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD	Cape Town Western Cape, ZA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004718255. Last updated year: 2026. Please use registration number 3004718255 when referencing this establishment in official correspondence.