Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Asahi Intecc Co., Ltd. — Predicate Candidate Screening
84 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
260 days90th percentile
84clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026-05-11 | 139 | 0 |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | 2026-02-02 | 220 | 0 |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025-06-20 | 30 | 0 |
| K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2025-06-20 | 59 | 0 |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025-04-21 | 172 | 0 |
| K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | 2025-04-02 | 119 | 0 |
| K241962 | Crossloop | Asahi Intecc Co., Ltd. | 2025-03-27 | 267 | 0 |
| K242597 | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | 2025-03-05 | 187 | 0 |
| K241702 | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | 2025-02-06 | 238 | 0 |
| K241801 | Tornus ES | Asahi Intecc Co., Ltd. | 2024-12-17 | 179 | 0 |
| K241510 | CROSSLEAD Tracker | Asahi Intecc Co., Ltd. | 2024-08-14 | 77 | 0 |
| K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus | Asahi Intecc Co., Ltd. | 2024-06-25 | 60 | 0 |
| K240387 | MINAMO blue; MINAMO viola | Asahi Intecc Co., Ltd. | 2024-06-21 | 134 | 0 |
| K230377 | CROSSLEAD Penetration Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2023-07-20 | 157 | 0 |
| K221951 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2022-10-11 | 98 | 0 |
| K213868 | ASAHI Gladius Mongo18 PV ES | Asahi Intecc Co., Ltd. | 2022-09-06 | 270 | 0 |
| K213315 | CROSSLEAD Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2022-07-01 | 270 | 0 |
| K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2022-03-24 | 132 | 0 |
| K203723 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2021-12-10 | 354 | 0 |
| K211898 | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 | Asahi Intecc Co., Ltd. | 2021-12-08 | 170 | 0 |
| K202252 | ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), A | Asahi Intecc Co., Ltd. | 2020-09-08 | 29 | 0 |
| K192599 | ASAHI PTCA Guide Wire ASAHI Gaia Next | Asahi Intecc Co., Ltd. | 2020-01-02 | 104 | 0 |
| K192782 | ASAHI CROSSWALK Peripheral Support Catheter | Asahi Intecc Co., Ltd. | 2019-11-29 | 60 | 0 |
| K191464 | Asahi PTCA Guide Wire Asahi SION Series | Asahi Intecc Co., Ltd. | 2019-11-21 | 171 | 0 |
| K190176 | MINAMO | Asahi Intecc Co., Ltd. | 2019-08-01 | 181 | 0 |
| K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | Asahi Intecc Co., Ltd. | 2019-07-26 | 30 | 0 |
| K183062 | ASAHI Silverway | Asahi Intecc Co., Ltd. | 2019-07-01 | 238 | 0 |
| K182844 | ASAHI SASUKE | Asahi Intecc Co., Ltd. | 2019-06-22 | 256 | 0 |
| K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 | Asahi Intecc Co., Ltd. | 2019-01-29 | 85 | 0 |
| K182420 | ASAHI Corsair Pro XS | Asahi Intecc Co., Ltd. | 2018-12-20 | 106 | 0 |
| K180784 | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius | Asahi Intecc Co., Ltd. | 2018-07-18 | 114 | 0 |
| K173277 | ASAHI PTCA Guide Wire ASAHI SION black | Asahi Intecc Co., Ltd. | 2018-07-05 | 265 | 0 |
| K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI C | Asahi Intecc Co., Ltd. | 2018-02-12 | 229 | 0 |
| K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft | Asahi Intecc Co., Ltd. | 2017-07-01 | 30 | 0 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI | Asahi Intecc Co., Ltd. | 2017-04-03 | 118 | 0 |
| K162842 | ASAHI PTCA Guide Wire ASAHI SUOH 03 | Asahi Intecc Co., Ltd. | 2017-01-27 | 108 | 0 |
| K161912 | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft t | Asahi Intecc Co., Ltd. | 2016-10-14 | 94 | 0 |
| K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 | Asahi Intecc Co., Ltd. | 2016-10-06 | 120 | 0 |
| K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | 2016-08-25 | 126 | 0 |
| K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | 2016-06-21 | 238 | 0 |
| K161362 | ASAHI Corsair Armet | Asahi Intecc Co., Ltd. | 2016-06-14 | 29 | 0 |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | Asahi Intecc Co., Ltd. | 2016-04-07 | 30 | 0 |
| K152249 | ASAHI Corsair Armet | Asahi Intecc Co., Ltd. | 2016-03-04 | 207 | 0 |
| K153443 | ASAHI Astato XS 40 | Asahi Intecc Co., Ltd. | 2016-02-25 | 90 | 0 |
| K152447 | ASAHI Caravel | Asahi Intecc Co., Ltd. | 2016-01-22 | 148 | 0 |
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Hal | Asahi Intecc Co., Ltd. | 2015-06-30 | 130 | 0 |
| K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2015-06-23 | 60 | 0 |
| K141981 | ASAHI FUBUKI 043 / ASAHI FUBUKI | Asahi Intecc Co., Ltd. | 2015-03-09 | 231 | 0 |
| K141751 | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEURO | Asahi Intecc Co., Ltd. | 2015-01-30 | 214 | 0 |
| K141339 | ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE | Asahi Intecc Co., Ltd. | 2014-10-23 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda