510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Asahi Intecc Co., Ltd.

SETO Aichi, JP

ASAHI INTECC CO., LTD. appears in FDA device records in SETO Aichi, JP. FDA records list 84 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
84
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 84

FDA records hold 84 510(k) clearances for Asahi Intecc Co., Ltd. between 2003 and 2026. The busiest year on record is 2016, with 9. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Asahi Intecc Co., Ltd., by decision year
YearClearances
20031
20041
20055
20064
20076
20082
20093
20103
20114
20121
20133
20142
20154
20169
20173
20184
20197
20202
20212
20224
20231
20244
20257
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254178SAYA 86 Radial Access Guide CatheterQJPSubstantially Equivalent
K252011CHIKAI Nexus petitMOFSubstantially Equivalent
K251560FUBUKI XF-R Neurovascular Long SheathQJPSubstantially Equivalent
K251240Branchor X Balloon Guide CatheterQJPSubstantially Equivalent
K243383CHIKAI Nexus 014MOFSubstantially Equivalent
K243733SION blue PLUSDQXSubstantially Equivalent
K241962CrossloopDQXSubstantially Equivalent
K242597CROSSLEAD 0.018inchDQXSubstantially Equivalent
K241702CROSSLEAD 0.014inchDQXSubstantially Equivalent
K241801Tornus ESFGESubstantially Equivalent
K241510CROSSLEAD TrackerDQXSubstantially Equivalent
K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3DQYSubstantially Equivalent
K240387MINAMO blue; MINAMO violaDQXSubstantially Equivalent
K230377CROSSLEAD Penetration Peripheral Guide WireDQXSubstantially Equivalent
K221951Branchor Balloon Guide CatheterQJPSubstantially Equivalent
K213868ASAHI Gladius Mongo18 PV ESDQXSubstantially Equivalent
K213315CROSSLEAD Peripheral Guide WireDQXSubstantially Equivalent
K213589FUBUKI XF Neurovascular Long SheathQJPSubstantially Equivalent
K203723Branchor Balloon Guide CatheterQJPSubstantially Equivalent
K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20DQXSubstantially Equivalent
K202252ASAHI 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),DQYSubstantially Equivalent
K192599ASAHI PTCA Guide Wire ASAHI Gaia NextDQXSubstantially Equivalent
K192782ASAHI CROSSWALK Peripheral Support CatheterDQYSubstantially Equivalent
K191464Asahi PTCA Guide Wire Asahi SION SeriesDQXSubstantially Equivalent
K190176MINAMODQXSubstantially Equivalent
K191714ASAHI Neurovascular Guide Wire CHIKAI X 014 softMOFSubstantially Equivalent
K183062ASAHI SilverwayDQXSubstantially Equivalent
K182844ASAHI SASUKEDQYSubstantially Equivalent
K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010MOFSubstantially Equivalent
K182420ASAHI Corsair Pro XSDQYSubstantially Equivalent
K180784ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ESDQXSubstantially Equivalent
K173277ASAHI PTCA Guide Wire ASAHI SION blackDQXSubstantially Equivalent
K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterDQXSubstantially Equivalent
K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipMOFSubstantially Equivalent
K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionDQXSubstantially Equivalent
K162842ASAHI PTCA Guide Wire ASAHI SUOH 03DQXSubstantially Equivalent
K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipMOFSubstantially Equivalent
K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16DQXSubstantially Equivalent
K161126ASAHI Corsair ProDQYSubstantially Equivalent
K153106ASAHI Fielder XT-A, ASAHI Fielder XT-RDQXSubstantially Equivalent
K161362ASAHI Corsair ArmetDQYSubstantially Equivalent
K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)MOFSubstantially Equivalent
K152249ASAHI Corsair ArmetDQYSubstantially Equivalent
K153443ASAHI Astato XS 40DQXSubstantially Equivalent
K152447ASAHI CaravelDQYSubstantially Equivalent
K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)DQXSubstantially Equivalent
K151103ASAHI Corsair MicrocatheterDQYSubstantially Equivalent
K141981ASAHI FUBUKI 043 / ASAHI FUBUKIDQYSubstantially Equivalent
K141751ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULARMOFSubstantially Equivalent
K141339ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIREDQXSubstantially Equivalent

Registered establishments

FDA registered establishments for Asahi Intecc Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30037750273003775027ASAHI INTECC CO., LTD.3-100 AKATSUKI-CHO, SETO Aichi 489-0071 JP2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain