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Asahi Intecc Co., Ltd. FDA Approvals
0 new drug approvals and 20 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| SAYA 86 Radial Access Guide Catheter510(k)May 11, 2026Cardiovascular |
| CHIKAI Nexus petit510(k)Feb 2, 2026Cardiovascular |
| FUBUKI XF-R Neurovascular Long Sheath510(k)Jun 20, 2025Cardiovascular |
| Branchor X Balloon Guide Catheter510(k)Jun 20, 2025Cardiovascular |
| CHIKAI Nexus 014510(k)Apr 21, 2025Cardiovascular |
| SION blue PLUS510(k)Apr 2, 2025Cardiovascular |
| Crossloop510(k)Mar 27, 2025Cardiovascular |
| CROSSLEAD 0.018inch510(k)Mar 5, 2025Cardiovascular |
| CROSSLEAD 0.014inch510(k)Feb 6, 2025Cardiovascular |
| Tornus ES510(k)Dec 17, 2024Gastroenterology, Urology |
| CROSSLEAD Tracker510(k)Aug 14, 2024Cardiovascular |
| ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3510(k)Jun 25, 2024Cardiovascular |
| MINAMO blue; MINAMO viola510(k)Jun 21, 2024Cardiovascular |
| CROSSLEAD Penetration Peripheral Guide Wire510(k)Jul 20, 2023Cardiovascular |
| Branchor Balloon Guide Catheter510(k)Oct 11, 2022Cardiovascular |
| ASAHI Gladius Mongo18 PV ES510(k)Sep 6, 2022Cardiovascular |
| CROSSLEAD Peripheral Guide Wire510(k)Jul 1, 2022Cardiovascular |
| FUBUKI XF Neurovascular Long Sheath510(k)Mar 24, 2022Cardiovascular |
| Branchor Balloon Guide Catheter510(k)Dec 10, 2021Cardiovascular |
| ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20510(k)Dec 8, 2021Cardiovascular |