Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003780911

FEI Number

3003780911

Entity Name

ASAHI INTECC (THAILAND) CO., LTD.

City/State/Country

Amphur Muang Pathumthani Pathum Thani, TH

Establishment Address

158/1 Moo 5, Bangkadi Idustrial Park, TIWANON ROAD, TAMBOL BANGKADI,, Amphur Muang Pathumthani Pathum Thani 12000, TH

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 PTCA Guide Wire ASAHI SION black FUBUKI XF Neurovascular Long Sheath ASAHI SION blue Phoenix Atherectomy Catheter, 1.8mm X 149cm Phoenix Atherectomy System, 1.8mm X 149cm Kit Phoenix Atherectomy System, 2.2mm X 149cm Kit Phoenix Handle with Wire Support Clip Phoenix Atherectomy Catheter, 2.2mm X 149cm VASSALLO GT Support VASSALLO GT Crossing VASSALLO GT Floppy ASAHI Corsair Pro XS CROSSLEAD Tracker VASSALLO GT 018 Floppy Regalia XS Tornus Phoenix Handle with Wire Support Clip CROSSLEAD Pro 035 ASAHI FUBUKI ASAHI FUBUKI 043 CROSSLEAD Pro 014 Miracle bros Confianza Pro Asahi Soft Miraclebros Prowater Grand Slam SION Phoenix Atherectomy Catheter, 1.8mm X 130cm Phoenix Handle with Wire Support Clip Phoenix Atherectomy System, 1.8mm X 130cm Kit Phoenix Atherectomy System, 2.2mm X 130cm Kit Phoenix Atherectomy Catheter, 2.2mm X 130cm X-treme Fielder Fielder FC Astato XS 20 Astato 30 ASAHI CHIKAI black 14 soft tip MINAMO ASAHI Corsair Armet 135cm ASAHI Corsair Armet 60cm ASAHI Corsair Armet 90cm ASAHI Corsair Armet 150cm ASAHI Corsair Pro 150cm ASAHI Corsair Pro 135cm ASAHI Gladius Mongo 18 PV ES Vassallo GT 018 Hybrid Gladius Mongo 14 Gladius Mongo 14 ES ASAHI Fielder XT-A ASAHI Fielder XT-A 300cm ASAHI Fielder XT-R ASAHI Fielder XT-R 300cm ASAHI SUOH 03 CROSSLEAD Pro 018 Treasure Floppy ASAHI Corsair Armet 18 Astato XS 40 FUBUKI XF-R Neurovascular Long Sheath Corsair Armet SheathLess Eaucath Coronary Guide Catheter ASAHI Tellus C3 ASAHI Tellus ASAHI Veloute ASAHI Veloute C3 SAYA 86 Radial Access Guide Catheter ASAHI Gaia First 300cm ASAHI Gaia Second Pre- shape ASAHI Gaia Second 300cm ASAHI Gaia Third 300cm ASAHI MIRACLEbros 6 300cm ASAHI ULTIMATEbros 3 180cm J ASAHI CONFIANZA PRO 12 180cm ASAHI MIRACLEbros 4.5 180cm ASAHI MIRACLEbros 6 180cm ASAHI FIELDER XT-A 300cm ASAHI MIRACLEbros 12 180cm ASAHI MIRACLEbros 3 180cm ASAHI Gaia Third Pre- shape ASAHI Gaia First ASAHI ULTIMATEbros 3 180cm ASAHI Gaia First 300cm Pre-shape ASAHI CONFIANZA PRO 300cm ASAHI Gaia Second 300cm Pre-shape ASAHI Gaia Third 300cm Pre-shape ASAHI Corsair Pro, 150cm ASAHI Gaia Third ASAHI CONFIANZA PRO 12 300cm ASAHI Corsair Pro, 135cm ASAHI ULTIMATEbros 3 300cm ASAHI FIELDER XT-A 190cm ASAHI Gaia Second ASAHI MIRACLEbros 12 300cm ASAHI FIELDER XT-R 300cm ASAHI FIELDER XT 190cm ASAHI Gaia First Pre- shape ASAHI FIELDER XT-R 190cm ASAHI MIRACLEbros 3 300cm ASAHI MIRACLEbros 4.5 300cm ASAHI CONFIANZA PRO 180cm ASAHI ULTIMATEbros 3 300cm J ASAHI FIELDER XT 300cm P15149K Phoenix Atherectomy System, 1.5mm X 149cm Kit PD24130 Phoenix Atherectomy Catheter, 2.4mm X 130cm PD24130K Phoenix Atherectomy System, 2.4mm X 130cm Kit P15149 Phoenix Atherectomy Catheter, 1.5mm X 149cm ASAHI SASUKE CONFIANZA PRO Prowater J Prowaterflex J Grand Slam J Confianza Pro J Miraclebros J Asahi Soft J Routreme J PD22130K Phoenix Atherectomy System, 2.2mm X 130cm Kit PD22130 Phoenix Atherectomy Catheter, 2.2mm X 130cm ASAHI RG3 Soft ASAHI RG3 CHIKAI ASAHI Gaia Next 1 ASAHI Gaia Next 2 ASAHI Gaia Next 3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-07-05
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	2013-11-18
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-08-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-06-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-12-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-08-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-09-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-01-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2006-01-03
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-08-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-07-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-05-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-02-09
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	2011-08-02
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-08-16
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	2011-11-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-01-27
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2016-10-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-08-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-06-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-08-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-09-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-03-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-07-19
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2021-12-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-12-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-06-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-09-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-02-25
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2025-06-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-03-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-11-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-06-28
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2026-05-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-02-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-02-12
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-02-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-03-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-06-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-02-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-10-24
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2011-12-19
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2019-10-24
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2019-10-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-01-06

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
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
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 3003780911. Last updated year: 2026. Please use registration number 3003780911 when referencing this establishment in official correspondence.