Asahi Intecc Co., Ltd. is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.
Asahi Intecc Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SAYA 86 Radial Access Guide Catheter, CHIKAI Nexus petit, Branchor X Balloon Guide Catheter
Asahi Intecc Co., Ltd. has 84 FDA 510(k) cleared cardiovascular devices. Based in Seto-Shi, JP.
Latest FDA clearance: May 2026. Active since 2003.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Asahi Intecc USA, Inc., CardioMed Device Consultants, LLC and Cardiomed Device Consultants. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Asahi Intecc Co., Ltd.
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