Company · JP
Asahi Intecc Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
85510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 11, 2026 | K254178 | SAYA 86 Radial Access Guide Catheter Asahi Intecc Co., Ltd., JP | QJP |
| Feb 2, 2026 | K252011 | CHIKAI Nexus petit Asahi Intecc Co., Ltd., JP | MOF |
| Jun 20, 2025 | K251560 | FUBUKI XF-R Neurovascular Long Sheath Asahi Intecc Co., Ltd., JP | QJP |
| Jun 20, 2025 | K251240 | Branchor X Balloon Guide Catheter Asahi Intecc Co., Ltd., JP | QJP |
| Apr 21, 2025 | K243383 | CHIKAI Nexus 014 Asahi Intecc Co., Ltd., JP | MOF |
| Apr 2, 2025 | K243733 | SION blue PLUS Asahi Intecc Co., Ltd., JP | DQX |
| Mar 27, 2025 | K241962 | Crossloop Asahi Intecc Co., Ltd., JP | DQX |
| Mar 5, 2025 | K242597 | CROSSLEAD 0.018inch Asahi Intecc Co., Ltd., JP | DQX |
| Feb 6, 2025 | K241702 | CROSSLEAD 0.014inch Asahi Intecc Co., Ltd., JP | DQX |
| Dec 17, 2024 | K241801 | Tornus ES Asahi Intecc Co., Ltd., JP | FGE |
| Aug 14, 2024 | K241510 | CROSSLEAD Tracker Asahi Intecc Co., Ltd., JP | DQX |
| Jun 25, 2024 | K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 Asahi Intecc Co., Ltd., JP | DQY |
| Jun 21, 2024 | K240387 | MINAMO blue; MINAMO viola Asahi Intecc Co., Ltd., JP | DQX |
| Jul 20, 2023 | K230377 | CROSSLEAD Penetration Peripheral Guide Wire Asahi Intecc Co., Ltd., JP | DQX |
| Oct 11, 2022 | K221951 | Branchor Balloon Guide Catheter Asahi Intecc Co., Ltd., JP | QJP |
| Sep 6, 2022 | K213868 | ASAHI Gladius Mongo18 PV ES Asahi Intecc Co., Ltd., JP | DQX |
| Jul 1, 2022 | K213315 | CROSSLEAD Peripheral Guide Wire Asahi Intecc Co., Ltd., JP | DQX |
| Mar 24, 2022 | K213589 | FUBUKI XF Neurovascular Long Sheath Asahi Intecc Co., Ltd., JP | QJP |
| Dec 10, 2021 | K203723 | Branchor Balloon Guide Catheter Asahi Intecc Co., Ltd., JP | QJP |
| Dec 8, 2021 | K211898 | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 Asahi Intecc Co., Ltd., JP | DQX |
| Sep 8, 2020 | K202252 | ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), AS Asahi Intecc Co., Ltd., JP | DQY |
| Jan 2, 2020 | K192599 | ASAHI PTCA Guide Wire ASAHI Gaia Next Asahi Intecc Co., Ltd., JP | DQX |
| Nov 29, 2019 | K192782 | ASAHI CROSSWALK Peripheral Support Catheter Asahi Intecc Co., Ltd., JP | DQY |
| Nov 21, 2019 | K191464 | Asahi PTCA Guide Wire Asahi SION Series Asahi Intecc Co., Ltd., JP | DQX |
| Aug 1, 2019 | K190176 | MINAMO Asahi Intecc Co., Ltd., JP | DQX |
| Jul 26, 2019 | K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft Asahi Intecc Co., Ltd., JP | MOF |
| Jul 1, 2019 | K183062 | ASAHI Silverway Asahi Intecc Co., Ltd., JP | DQX |
| Jun 22, 2019 | K182844 | ASAHI SASUKE Asahi Intecc Co., Ltd., JP | DQY |
| Jan 29, 2019 | K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 Asahi Intecc Co., Ltd., JP | MOF |
| Dec 20, 2018 | K182420 | ASAHI Corsair Pro XS Asahi Intecc Co., Ltd., JP | DQY |
| Jul 18, 2018 | K180784 | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES Asahi Intecc Co., Ltd., JP | DQX |
| Jul 5, 2018 | K173277 | ASAHI PTCA Guide Wire ASAHI SION black Asahi Intecc Co., Ltd., JP | DQX |
| Feb 12, 2018 | K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter Asahi Intecc Co., Ltd., JP | DQX |
| Jul 1, 2017 | K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip Asahi Intecc Co., Ltd., JP | MOF |
| Apr 3, 2017 | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension Asahi Intecc Co., Ltd., JP | DQX |
| Jan 27, 2017 | K162842 | ASAHI PTCA Guide Wire ASAHI SUOH 03 Asahi Intecc Co., Ltd., JP | DQX |
| Oct 14, 2016 | K161912 | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip Asahi Intecc Co., Ltd., JP | MOF |
| Oct 6, 2016 | K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 Asahi Intecc Co., Ltd., JP | DQX |
| Aug 25, 2016 | K161126 | ASAHI Corsair Pro Asahi Intecc Co., Ltd., JP | DQY |
| Jun 21, 2016 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R Asahi Intecc Co., Ltd., JP | DQX |
| Jun 14, 2016 | K161362 | ASAHI Corsair Armet Asahi Intecc Co., Ltd., JP | DQY |
| Apr 7, 2016 | K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) Asahi Intecc Co., Ltd. | MOF |
| Mar 4, 2016 | K152249 | ASAHI Corsair Armet Asahi Intecc Co., Ltd., JP | DQY |
| Feb 25, 2016 | K153443 | ASAHI Astato XS 40 Asahi Intecc Co., Ltd., JP | DQX |
| Jan 22, 2016 | K152447 | ASAHI Caravel Asahi Intecc Co., Ltd., JP | DQY |
| Jun 30, 2015 | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) Asahi Intecc Co., Ltd., JP | DQX |
| Jun 23, 2015 | K151103 | ASAHI Corsair Microcatheter Asahi Intecc Co., Ltd., JP | DQY |
| Mar 9, 2015 | K141981 | ASAHI FUBUKI 043 / ASAHI FUBUKI Asahi Intecc Co., Ltd. | DQY |
| Jan 30, 2015 | K141751 | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR Asahi Intecc Co., Ltd. | MOF |
| Oct 23, 2014 | K141339 | ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE Asahi Intecc Co., Ltd. | DQX |
Newest 50 of 85.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||