FDA.reportPublic FDA data

ASAHI INTECC CO., LTD.

Matched from indexed company URL: Asahi Intecc Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037750273003775027ASAHI INTECC CO., LTD.1N2026-01-013-100 AKATSUKI-CHO SETO Aichi JP 489-0071

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
209701925950142K254178SAYA 86 Radial Access Guide CatheterQJP2026-05-11
209702026344971K252011CHIKAI Nexus petitMOF2026-02-02
209701167970892K251560FUBUKI XF-R Neurovascular Long SheathQJP2025-06-20
209701760663719K251240Branchor X Balloon Guide CatheterQJP2025-06-20
209701905991960K243733SION blue PLUSDQX2025-04-02
209701027641273K243383CHIKAI Nexus 014MOF2025-04-21
209701722525426K242597CROSSLEAD 0.018inchDQX2025-03-05
209701753902737K241962CrossloopDQX2025-03-27
209701938872588K241801Tornus ESFGE2024-12-17
209701632104491K241702CROSSLEAD 0.014inchDQX2025-02-06
209701305338890K241510CROSSLEAD TrackerDQX2024-08-14
209701454461450K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3DQY2024-06-25
209701081771370K240387MINAMO blue; MINAMO violaDQX2024-06-21
209701116109167K230377CROSSLEAD Penetration Peripheral Guide WireDQX2023-07-20
209701101354882K221951Branchor Balloon Guide CatheterQJP2022-10-11
209701860602297K213868ASAHI Gladius Mongo18 PV ESDQX2022-09-06
209702024346449K213589FUBUKI XF Neurovascular Long SheathQJP2022-03-24
209701291607722K213315CROSSLEAD Peripheral Guide WireDQX2022-07-01
209701770806493K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20DQX2021-12-08
209701916780066K203723Branchor Balloon Guide CatheterQJP2021-12-10
209701106826550K203533VASSALLO GTDQX2021-04-21
209701053275210K203529VASSALLO GT HybridDQX2021-05-04
209701756962932K202252ASAHI 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),DQY2020-09-08
209701092939374K192782ASAHI CROSSWALK Peripheral Support CatheterDQY2019-11-29
209701601676708K192599ASAHI PTCA Guide Wire ASAHI Gaia NextDQX2020-01-02
209701311234555K191714ASAHI Neurovascular Guide Wire CHIKAI X 014 softMOF2019-07-26
209701912610715K191464Asahi PTCA Guide Wire Asahi SION SeriesDQX2019-11-21
209701863501570K190176MINAMODQX2019-08-01
209701727646544K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010MOF2019-01-29
209701111149456K183062ASAHI SilverwayDQX2019-07-01
209701015781909K182844ASAHI SASUKEDQY2019-06-22
209701892027357K182420ASAHI Corsair Pro XSDQY2018-12-20
209701299113610K180784ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ESDQX2018-07-18
209701822045995K173277ASAHI PTCA Guide Wire ASAHI SION blackDQX2018-07-05
209701092535263K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterDQX2018-02-12
209701080243164K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipMOF2017-07-01
209701194076658K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionDQX2017-04-03
209701838829654K162842ASAHI PTCA Guide Wire ASAHI SUOH 03DQX2017-01-27
209701039417666K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipMOF2016-10-14
209701253352532K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16DQX2016-10-06
209701178501076K161362ASAHI Corsair ArmetDQY2016-06-14
209701324992419K161126ASAHI Corsair ProDQY2016-08-25
209701586172312K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)MOF2016-04-07
209701494585208K153443ASAHI Astato XS 40DQX2016-02-25
209701225354188K153106ASAHI Fielder XT-A, ASAHI Fielder XT-RDQX2016-06-21
209701767550600K152447ASAHI CaravelDQY2016-01-22
209701433550324K152249ASAHI Corsair ArmetDQY2016-03-04
209701066471568K151103ASAHI Corsair MicrocatheterDQY2015-06-23
209701416961151K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)DQX2015-06-30
209701810530716K141981ASAHI FUBUKI 043 / ASAHI FUBUKIDQY2015-03-09
209701203737419K141751ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULARMOF2015-01-30
209701008592848K141339ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIREDQX2014-10-23
209701375364591K133865ASAHI GAIA FIRST, SECOND, THIRDDQX2014-03-18
209701055248699K132556SHEATHLESS EAUCATH CORONARY GUIDE CATHETERDQY2013-10-24
209701192177569K122469ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJDQX2013-03-08
209701933698304K122468ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIODQX2013-03-08
209701850453084K113716ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIREDQX2012-02-06
209701406776338K112979ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIREMOF2011-12-01
209701707193533K110584ASAHI CHIKAI NEUROVASCULAR GUIDE WIREMOF2011-08-22
209701829588046K110553ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIREDQX2011-03-18
209701071860204K103057ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIREDQX2010-11-19
209701740259455K101986ASAHI ULTIMATEBROS 3 PTCA GUIDE WIREDQX2011-09-09
209701690801247K101985ASAHI GUIDE WIRE EXTENSION 165CMDQX2011-03-07
209701160271182K100578ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301SDQX2010-09-22
209701224730248K083146ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000DQX2008-11-21
209701242812599K083145ASAHI GUIDE WIRE EXTENSION, MODEL AG149000DQX2009-01-12
209701754165778K083127ASAHI CORSAIR MICROCATHETERDQY2009-02-03
209701115600501K072705ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301JDQX2007-10-23
209701901593689K072431ASAHI PTCA GUIDE WIRE, X-TREMEDQX2007-09-26
209701682696717K071721ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371DQX2007-07-13
209701133389543K063819ASAHI PTCA GUIDE WIRE, FIELDER FCDQX2007-01-26
209701259833874K062186ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300JDQX2006-11-09
209701389471054K061984TREASUREDQX2006-10-05
209701008970427K052339ASAHI PTCA GUIDE WIREDQX2005-11-30
209701973259848K052022ASAHI PTCA GUIDE WIRE FIELDERDQX2005-08-25
209701143625536K051772ASAHI TORNUS SUPPORT CATHETERDQY2005-09-26
209701851795453K043422ASAHI PTCA GUIDE WIRE, J SHAPE SERIESDQX2005-01-12
209701746103862K041531ASAHI PTCA GUIDE WIRE CONFIANZA PRODQX2004-08-03
209701232932221K032615ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300DQX2003-09-16
209701913768571K031277JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002DQX2003-05-14
209701140727821K022762JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050DQX2002-12-16
209701974573934

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX502025-04-02
DQY142024-06-25
MOF102026-02-02
QJP62026-05-11
FGE12024-12-17

PMN#

MINAMO

2019-08-01

Asahi Intecc Co., Ltd.

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GUDID#

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