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
84
Total
84
Cleared
0
Denied
FDA 510(k) Regulatory Record - Asahi Intecc Co., Ltd. Cardiovascular ✕
67 devices
Cleared
Apr 02, 2025
SION blue PLUS
Cardiovascular
119d
Cleared
Mar 27, 2025
Crossloop
Cardiovascular
267d
Cleared
Mar 05, 2025
CROSSLEAD 0.018inch
Cardiovascular
187d
Cleared
Feb 06, 2025
CROSSLEAD 0.014inch
Cardiovascular
238d
Cleared
Aug 14, 2024
CROSSLEAD Tracker
Cardiovascular
77d
Cleared
Jun 25, 2024
ASAHI Veloute
Cardiovascular
60d
Cleared
Jun 21, 2024
MINAMO blue
Cardiovascular
134d
Cleared
Jul 20, 2023
CROSSLEAD Penetration Peripheral Guide Wire
Cardiovascular
157d
Cleared
Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
Cardiovascular
270d
Cleared
Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
Cardiovascular
270d
Cleared
CT
Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
Cardiovascular
170d
Cleared
Sep 08, 2020
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair...
Cardiovascular
29d
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