Data / Medical devices / Japan / Asahi Intecc Co., Ltd.

Asahi Intecc Co., Ltd.: FDA-registered device maker in SETO Aichi, Japan, 78 510(k) clearances

Name: Asahi Intecc Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Asahi Intecc Co., Ltd. is registered with the FDA (registration 3003775027) in SETO Aichi, Japan. It lists 6 device types. The FDA files 78 510(k) clearances under its listings, the newest dated May 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Asahi Intecc Co., Ltd.

FDA registration number: 3003775027
Address: 3-100 Akatsuki-Cho, SETO Aichi, Japan, 489-0071
Owner or operator: ASAHI INTECC CO., LTD. (9051916)
Roles: Manufacturer, Specification developer
First device listed: January 3, 2006
Registered through: 2026
Brand names listed: ASAHI CHIKAI X 010, ASAHI CHIKAI black 14 soft tip, ASAHI CHIKAI black 18 soft tip, ASAHI CONFIANZA PRO 12 180cm, ASAHI CONFIANZA PRO 12 300cm, ASAHI CONFIANZA PRO 180cm, ASAHI CONFIANZA PRO 300cm, ASAHI CROSSWALK Peripheral Support Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer, Specification developer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Manufacturer, Specification developer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Manufacturer, Specification developer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer, Specification developer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 11, 2026	K254178	SAYA 86 Radial Access Guide Catheter	QJP	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
February 2, 2026	K252011	CHIKAI Nexus petit	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 20, 2025	K251560	FUBUKI XF-R Neurovascular Long Sheath	QJP	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 20, 2025	K251240	Branchor X Balloon Guide Catheter	QJP	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
April 21, 2025	K243383	CHIKAI Nexus 014	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
April 2, 2025	K243733	SION blue PLUS	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 27, 2025	K241962	Crossloop	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 5, 2025	K242597	CROSSLEAD 0.018inch	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
February 6, 2025	K241702	CROSSLEAD 0.014inch	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
December 17, 2024	K241801	Tornus ES	FGE	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
August 14, 2024	K241510	CROSSLEAD Tracker	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 25, 2024	K241158	ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 21, 2024	K240387	MINAMO blue; MINAMO viola	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 20, 2023	K230377	CROSSLEAD Penetration Peripheral Guide Wire	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
October 11, 2022	K221951	Branchor Balloon Guide Catheter	QJP	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
September 6, 2022	K213868	ASAHI Gladius Mongo18 PV ES	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 1, 2022	K213315	CROSSLEAD Peripheral Guide Wire	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 24, 2022	K213589	FUBUKI XF Neurovascular Long Sheath	QJP	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
December 10, 2021	K203723	Branchor Balloon Guide Catheter	QJP	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
December 8, 2021	K211898	ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
May 4, 2021	K203529	VASSALLO GT Hybrid	DQX	Substantially Equivalent	Filmecc Co., Ltd.	accessdata.fda.gov
April 21, 2021	K203533	VASSALLO GT	DQX	Substantially Equivalent	Filmecc Co., Ltd.	accessdata.fda.gov
September 8, 2020	K202252	ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
January 2, 2020	K192599	ASAHI PTCA Guide Wire ASAHI Gaia Next	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
November 29, 2019	K192782	ASAHI CROSSWALK Peripheral Support Catheter	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
November 21, 2019	K191464	Asahi PTCA Guide Wire Asahi SION Series	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
August 1, 2019	K190176	MINAMO	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 26, 2019	K191714	ASAHI Neurovascular Guide Wire CHIKAI X 014 soft	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 1, 2019	K183062	ASAHI Silverway	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 22, 2019	K182844	ASAHI SASUKE	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
January 29, 2019	K183070	ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
December 20, 2018	K182420	ASAHI Corsair Pro XS	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 18, 2018	K180784	ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 5, 2018	K173277	ASAHI PTCA Guide Wire ASAHI SION black	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
February 12, 2018	K171933	ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 1, 2017	K171613	ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
April 3, 2017	K163426	ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
January 27, 2017	K162842	ASAHI PTCA Guide Wire ASAHI SUOH 03	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
October 14, 2016	K161912	ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
October 6, 2016	K161584	ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
August 25, 2016	K161126	ASAHI Corsair Pro	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 21, 2016	K153106	ASAHI Fielder XT-A, ASAHI Fielder XT-R	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 14, 2016	K161362	ASAHI Corsair Armet	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
April 7, 2016	K160659	ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 4, 2016	K152249	ASAHI Corsair Armet	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
February 25, 2016	K153443	ASAHI Astato XS 40	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
January 22, 2016	K152447	ASAHI Caravel	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
June 30, 2015	K150445	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 9, 2015	K141981	ASAHI FUBUKI 043 / ASAHI FUBUKI	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
January 30, 2015	K141751	ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
October 23, 2014	K141339	ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 18, 2014	K133865	ASAHI GAIA FIRST, SECOND, THIRD	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
October 24, 2013	K132556	SHEATHLESS EAUCATH CORONARY GUIDE CATHETER	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 8, 2013	K122469	ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 8, 2013	K122468	ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
February 6, 2012	K113716	ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
December 1, 2011	K112979	ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
September 9, 2011	K101986	ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
August 22, 2011	K110584	ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE	MOF	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
March 18, 2011	K110553	ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE	DQX	Substantially Equivalent	Asahi Intecc USA, Inc.	accessdata.fda.gov
March 7, 2011	K101985	ASAHI GUIDE WIRE EXTENSION 165CM	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
November 19, 2010	K103057	ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
September 22, 2010	K100578	ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
November 21, 2008	K083146	ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
October 23, 2007	K072705	ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
September 26, 2007	K072431	ASAHI PTCA GUIDE WIRE, X-TREME	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
July 13, 2007	K071721	ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
January 26, 2007	K063819	ASAHI PTCA GUIDE WIRE, FIELDER FC	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
November 9, 2006	K062186	ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
October 5, 2006	K061984	TREASURE	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
November 30, 2005	K052339	ASAHI PTCA GUIDE WIRE	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
September 26, 2005	K051772	ASAHI TORNUS SUPPORT CATHETER	DQY	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
August 25, 2005	K052022	ASAHI PTCA GUIDE WIRE FIELDER	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
January 12, 2005	K043422	ASAHI PTCA GUIDE WIRE, J SHAPE SERIES	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
August 3, 2004	K041531	ASAHI PTCA GUIDE WIRE CONFIANZA PRO	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
September 16, 2003	K032615	ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300	DQX	Substantially Equivalent	Asahi Intecc Co., Ltd.	accessdata.fda.gov
May 14, 2003	K031277	JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002	DQX	Substantially Equivalent	Jomed, Inc.	accessdata.fda.gov
December 16, 2002	K022762	JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050	DQX	Substantially Equivalent	Jomed, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.