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ASAHI INTECC CO., LTD.

Japan·JP-MF-000010199

Last updated September 17, 2026

Information

Country: Japan
Address: 3-100 Akatsuki-cho, Seto, Japan
Website: asahi-intecc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yasuyuki Kawahara
EUDAMED SRN: JP-MF-000010199
FDA FEI Number: 3003775027
DUNS Number: —

Catalogue (919)

Page 1 of 19

Device	Model / Reference	Registries	Class	Status
SAYA 86 Radial Access Guide Catheter	K254178	FDA 510(k)	Class II	Active
Asahi Ptca Guide Wire, Fielder Fc J, Models: Agp140001j, Agp140301j	K072705	FDA 510(k)	Class II	Active
ASAHI PTCA GUIDE WIRE FIELDER FC 300cm	AGP140301	EUDAMEDFDA UDI	Class III	Active
ASAHI Corsair Pro	K161126	FDA 510(k)	Class II	Active
ASAHI Silverway	K183062	FDA 510(k)	Class II	Active
ASAHI Gladius MG14 ES 300cm Pre-shape	AP14R324P	EUDAMEDFDA UDI	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FR45-0-X100S	EUDAMED	Class III	Active
The ASAHI Tornus 2.1 Fr Support Catheter	AT24135	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Short Amplatz Left 2.0cm, Side Hole	HW80AL202P09002	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8CL50-0-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6FR35-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Super Power Backup 3.0cm	HW80SP300P09000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FR45-0-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Amplatz Left 1.5cm, Side Hole	HW60AL152P09000	EUDAMED	Class III	Active
SheathLess Eaucath PTCA Guiding Catheter, 7.5 Fr, Judkins Left 5.0cm, Short Tip, 100cm	G7JL50-0-L100S	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire MIRACLEbros 6	AG14M060	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7FL35-2-X100	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire ASAHI SION black 300cm J	APW14R310J	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire CONFIANZA	AG143090	EUDAMED	Class III	Active
ASAHI NEO'S PTCA Guide Wire Soft 300cm J	AG141300J	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8CL50-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Hockey Stick 01, Side Hole	HW60HS012P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7CP10-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Power Backup 3.0cm	HW70PB300P10000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6AL20-0-X100S	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Hockey Stick 02	HW80HS020P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Short Amplatz Left 0.75cm, Side Hole	HW80AL072P09002	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W6CL35-2-X100	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W7PB35-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Power Backup 3.5cm	HW70PB350P09000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Super Power Backup 3.0cm	HW70SP300P09000	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-8S80	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Amplatz Left 1.0cm, Side Hole	HW60AL102P09000	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8AL07-2-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Right 3.5cm	HW80JR350P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Special Curve 3.5cm	HW80SC350P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Power Backup 4.0cm	HW60PB400P09000	EUDAMED	Class III	Active
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit	WAIN-FBK-5ADLH	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8FL40-2-X100S	EUDAMED	Class III	Active
ASAHI Peripheral Guide Wire Treasure 12	PAGH18M070	EUDAMED	Class IIa	Active
ASAHI PTCA Guide Wire Conquest 300cm J	AG143390J	EUDAMED	Class III	Active
ASAHI ZenyteEX PTCA GUIDING CATHETER	W8MP01-0-X100	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Judkins Right 4.0cm	HW60JR400P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Champ 1.5cm	HW80CP150P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Power Backup 3.0cm	HW60PB300P09000	EUDAMED	Class III	Active
ASAHI PTCA Guide Wire Miracle 4.5 J	AG14M045J	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Shepherd's Crook 3.5cm	HW70SA350P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Champ 3.0cm	HW60CP300P10000	EUDAMED	Class III	Active
ASAHI Hyperion Coronary Guide Catheter, 100cm, 6Fr, Short Amplatz Left 1.5cm, Side Hole	HW60AL152P10002	EUDAMED	Class III	Active
ASAHI NEO'S 3M Miracle 6	AG14M360	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Asahi Intecc Co., Ltd. US