FDA 510(k) Applications Submitted by Katsuhiko Fujimura

FDA 510(k) Number Submission Date Device Name Applicant
K230377 02/13/2023 CROSSLEAD Penetration Peripheral Guide Wire ASAHI INTECC Co., Ltd.
K241510 05/29/2024 CROSSLEAD Tracker ASAHI INTECC CO., LTD.
K241702 06/13/2024 CROSSLEAD 0.014inch Asahi Intecc Co., Ltd.
K241801 06/21/2024 Tornus ES ASAHI Intecc Co., Ltd.
K241962 07/03/2024 Crossloop Asahi Intecc Co., Ltd.
K221951 07/05/2022 Branchor Balloon Guide Catheter Asahi Intecc Co., Ltd
K242597 08/30/2024 CROSSLEAD 0.018inch Asahi Intecc Co., Ltd.
K243383 10/31/2024 CHIKAI Nexus 014 ASAHI INTECC CO., LTD.
K243733 12/04/2024 SION blue PLUS ASAHI INTECC CO., LTD.


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