BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ASAHI INTECC CO., LTD.

    Reg #: 3003775027 · FEI: 3003775027 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    174
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    ASAHI INTECC CO., LTD.
    Registration Number
    3003775027
    FEI Number
    3003775027
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-100 AKATSUKI-CHO
    City
    SETO Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K192599

    Owner / Operator

    Firm Name
    ASAHI INTECC CO., LTD.
    Operator Number
    9051916
    Address
    3-100 Akatsuki-cho, --
    City
    Seto
    State
    Aichi
    Postal Code
    489-0071
    Country
    JP

    US Agent

    Business Name
    ASAHI INTECC CO., LTD.
    Contact Name
    Ariel Barrett
    Address
    22 Executive Park, Suite 110
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 7568636

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Catheter, Percutaneous, Neurovasculature QJP
    Guide, Wire, Catheter, Neurovasculature MOF
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Catheter, Percutaneous DQY
    Stents, Drains And Dilators For The Biliary Ducts FGE

    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 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 PROWATER ASAHI Gladius18 MIRACLEBROS 3 Treasure 12 MIRACLEBROS 6 Astato XS 20 ASAHI Gaia First ULTIMATEbros 3 ASAHI Gaia PV18 PROWATERflex FIELDER FIELDER XT SOFT GRAND SLAM CONFIANZA PRO 12 MIRACLEBROS 12 ASAHI Gaia Third EXTENSION FIELDER XT-A ASAHI Gaia Second FIELDER FC Astato XS40 Regalia XS 1 ASAHI SION FIELDER XT-R Halberd18 ASAHI CHIKAI X 010 CROSSLEAD Pro 018 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 Corsair Armet CROSSLEAD Pro 014 ASAHI Caravel ASAHI RG3 Soft ASAHI RG3 ASAHI Neurovascular Guide Wire ASAHI CHIKAI black ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008 ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18 Tornus 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 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 CONFIANZA PRO 12 300cm ASAHI Corsair Pro, 135cm ASAHI ULTIMATEbros 3 300cm ASAHI FIELDER XT-A 190cm 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 Miracle bros Confianza Pro ASAHI Corsair Pro 150cm ASAHI Corsair Pro 135cm Branchor X Balloon Guide Catheter ASAHI Silverway ASAHI Gladius Mongo 18 PV ES Miracle 6 Miraclebros 6 Rinato Miraclebros 3 Miracle 3 FUBUKI XF-R Neurovascular Long Sheath Tornus ES

    Establishment Types

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