Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009121749

FEI Number

3009121749

Entity Name

ASAHI INTECC HANOI CO., LTD.

City/State/Country

Hanoi Ha Noi, VN

Establishment Address

Plot G-3, Thang Long Industrial Park, Thien Loc Commune,, Hanoi Ha Noi 12332, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

ASAHI Corsair Pro 150cm ASAHI Corsair Pro 135cm CONFIANZA PRO 8-20 Fielder J CHIKAI CONFIANZA PRO ULTIMATEbros ASAHI Silverway ASAHI Gladius ASAHI Halberd ASAHI Gaia PV ASAHI Neurovascular Guide Wire CHIKAI X 014 soft ASAHI Fielder XT-A ASAHI Fielder XT-A 300cm ASAHI Fielder XT-R ASAHI Fielder XT-R 300cm Treasure Floppy Astato XS 20 CHIKAI Regalia XS Astato XS 40 ASAHI PTCA Guide Wire ASAHI SION black CHIKAI Nexus petit Miracle 6 Miraclebros 6 Rinato Miraclebros 3 Prowater Grand Slam Asahi Soft Miracle 3 ASAHI Gaia Fielder FC ASAHI Meister 16 165cm ANGLED DOUBLE ASAHI Meister 16 180cm ANGLED 45degree ASAHI Meister 16 135cm ANGLED DOUBLE ASAHI Meister 16 165cm Round curve Re- Shapable ASAHI Meister 16 165cm ANGLED 45degree ASAHI Meister 16 180cm ANGLED DOUBLE ASAHI Meister 16 180cm Round curve Re- Shapable ASAHI Meister 16 135cm Round curve Re-Shapable ASAHI Meister 16 135cm ANGLED 45degree CHIKAI Round Curve CHIKAI Nexus 014 ASAHI RG3 Soft ASAHI RG3 ASAHI SION blue ASAHI SUOH 03 Treasure ASAHI Caravel ASAHI CHIKAI black 14 soft tip Miracle bros Confianza Pro ASAHI CHIKAI black 18 soft tip ASAHI Neurovascular Guide Wire ASAHI CHIKAI black ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008 ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18 ASAHI CHIKAI X 010 CHIKAI V ASAHI SION blue ASAHI SION Prowater J Prowaterflex J Grand Slam J Confianza Pro J Miraclebros J Asahi Soft J Routreme J Tornus ES Gladius Mongo 14 Gladius Mongo 14 ES Astato 30 PROWATER Treasure Floppy ASAHI Gladius18 MIRACLEBROS 3 Treasure 12 MIRACLEBROS 6 Astato XS 20 ASAHI Gaia First ULTIMATEbros 3 ASAHI Gaia PV18 CONFIANZA PRO PROWATERflex FIELDER FIELDER XT SOFT GRAND SLAM CONFIANZA PRO 12 MIRACLEBROS 12 ASAHI Gaia Third EXTENSION ASAHI SION blue FIELDER XT-A ASAHI Gaia Second FIELDER FC Astato XS40 Regalia XS 1 ASAHI SION FIELDER XT-R Halberd18 ASAHI CROSSWALK Peripheral Support Catheter SION CROSSLOOP Asahi Soft Miraclebros Prowater Grand Slam Fielder FC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-08-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-12-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2011-12-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-07-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-07-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-07-01
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-07-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-06-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-18
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2011-08-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-01-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-02-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-07-05
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2026-02-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-03-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-10-17
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2016-04-13
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2025-04-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-10-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-11-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-01-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-03-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-01-25
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2016-10-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2017-07-02
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2015-02-03
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-08-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2024-12-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-07-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-04-13
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2017-04-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-12-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-08-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-31
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Ariel Barrett Business: ASAHI INTECC CO., LTD. Email: ariel.barrett@asahi-intecc-us.com Phone: (949) 7568636

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
3004718255	ASAHI INTECC USA, INC.	Tustin, CA, US
3016119728	Toyoflex Cebu Corporation	Lapu-Lapu Cebu, PH
3003780911	ASAHI INTECC (THAILAND) CO., LTD.	Amphur Muang Pathumthani Pathum Thani, TH
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009121749. Last updated year: 2026. Please use registration number 3009121749 when referencing this establishment in official correspondence.