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. Neurology ✕
16 devices
Cleared
May 11, 2026
SAYA 86 Radial Access Guide Catheter
Neurology
139d
Cleared
Feb 02, 2026
CHIKAI Nexus petit
Neurology
220d
Cleared
Jun 20, 2025
Branchor X Balloon Guide Catheter
Neurology
59d
Cleared
Jun 20, 2025
FUBUKI XF-R Neurovascular Long Sheath
Neurology
30d
Cleared
Apr 21, 2025
CHIKAI Nexus 014
Neurology
172d
Cleared
Oct 11, 2022
Branchor Balloon Guide Catheter
Neurology
98d
Cleared
Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
Neurology
132d
Cleared
Dec 10, 2021
Branchor Balloon Guide Catheter
Neurology
354d
Cleared
Jul 26, 2019
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
Neurology
30d
Cleared
Jan 29, 2019
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
Neurology
85d
Cleared
Jul 01, 2017
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
Neurology
30d
Cleared
Oct 14, 2016
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
Neurology
94d
Cleared
Apr 07, 2016
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
Neurology
30d
Cleared
Jan 30, 2015
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE...
Neurology
214d
Cleared
Dec 01, 2011
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
Neurology
56d
Cleared
Aug 22, 2011
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
Neurology
174d