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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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