Asahi Intecc Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
83
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252011CHIKAI Nexus petitFebruary 2, 2026
K251240Branchor X Balloon Guide CatheterJune 20, 2025
K251560FUBUKI XF-R Neurovascular Long SheathJune 20, 2025
K243383CHIKAI Nexus 014April 21, 2025
K243733SION blue PLUSApril 2, 2025
K241962CrossloopMarch 27, 2025
K242597CROSSLEAD 0.018inchMarch 5, 2025
K241702CROSSLEAD 0.014inchFebruary 6, 2025
K241801Tornus ESDecember 17, 2024
K241510CROSSLEAD TrackerAugust 14, 2024
K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3June 25, 2024
K240387MINAMO blue; MINAMO violaJune 21, 2024
K230377CROSSLEAD Penetration Peripheral Guide WireJuly 20, 2023
K221951Branchor Balloon Guide CatheterOctober 11, 2022
K213868ASAHI Gladius Mongo18 PV ESSeptember 6, 2022
K213315CROSSLEAD Peripheral Guide WireJuly 1, 2022
K213589FUBUKI XF Neurovascular Long SheathMarch 24, 2022
K203723Branchor Balloon Guide CatheterDecember 10, 2021
K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20December 8, 2021
K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (ModSeptember 8, 2020