Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003775027

FEI Number

3003775027

Entity Name

ASAHI INTECC CO., LTD.

City/State/Country

SETO Aichi, JP

Establishment Address

3-100 AKATSUKI-CHO, SETO Aichi 489-0071, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

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

K152249

PMA Number

N/A

All Registered Proprietary Names

ASAHI Gaia Next 1 ASAHI Gaia Next 2 ASAHI Gaia Next 3 CONFIANZA PRO Astato XS 40 SAYA 86 Radial Access Guide Catheter CROSSLEAD Pro 035 Fielder FC Treasure CHIKAI Nexus 014 ULTIMATEbros SION ASAHI Gladius ASAHI Halberd ASAHI Gaia PV VASSALLO GT Hybrid ASAHI CHIKAI black 18 soft tip MINAMO blue MINAMO viola Regalia XS CHIKAI Nexus petit Fielder 18 Endoscopic Guide Wire ASAHI Fielder XT-A ASAHI Fielder XT-A 300cm ASAHI Fielder XT-R ASAHI Fielder XT-R 300cm ASAHI Tellus C3 ASAHI Tellus ASAHI Veloute ASAHI Veloute C3 Prowaterflex Routreme Fielder FC ASAHI Gaia ASAHI Corsair Pro XS CHIKAI ASAHI SION blue Treasure Floppy CHIKAI V Branchor Balloon Guide Catheter ASAHI CHIKAI black 14 soft tip ASAHI Neurovascular Guide Wire CHIKAI X 014 soft Prowater J Prowaterflex J Grand Slam J Confianza Pro J Miraclebros J Asahi Soft J Routreme J Astato 30 ASAHI SASUKE CROSSLEAD Penetration Peripheral Guide Wire SheathLess Eaucath Coronary Guide Catheter FUBUKI XF Neurovascular Long Sheath CONFIANZA PRO 8-20 CROSSLEAD Tracker X-treme Fielder Asahi Soft Miraclebros Prowater Grand Slam Gladius Mongo 14 Gladius Mongo 14 ES ASAHI PTCA Guide Wire ASAHI SION black MINAMO ASAHI SUOH 03 Fielder J CROSSLOOP ASAHI FUBUKI ASAHI FUBUKI 043 ASAHI Corsair Armet 135cm ASAHI Corsair Armet 60cm ASAHI Corsair Armet 90cm ASAHI Corsair Armet 150cm CHIKAI Round Curve ASAHI CROSSWALK Peripheral Support Catheter SION blue PLUS 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 CHIKAI X 010 ASAHI SION blue ASAHI SION CROSSLEAD Pro 018 CHIKAI VASSALLO GT Support VASSALLO GT Crossing VASSALLO GT Floppy ASAHI Corsair Armet 18 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 Astato XS 20 Corsair Armet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-01-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-02-25
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2026-05-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-07-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-01-27
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2025-04-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-07-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-08-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-07-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-06-10
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2017-07-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-06-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-01-27
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2026-02-04
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-07-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-06-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-06-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-03-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-12-20
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2011-12-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-11-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-08-06
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-10-26
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2016-10-17
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-07-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-01-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-06-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-03-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-07-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-11-18
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-03-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-03-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-12-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-08-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-07-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-07-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-08-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-31
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-05-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-06-14
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2016-04-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-12-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-04-03
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
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-09
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2011-08-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-06-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-09-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-10-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-03-06

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
3009121749	ASAHI INTECC HANOI CO., LTD.	Hanoi Ha Noi, VN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
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.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003775027. Last updated year: 2026. Please use registration number 3003775027 when referencing this establishment in official correspondence.