Medical Device Manufacturer · JP , Seto-Shi

Asahi Intecc Co., Ltd.

83 submissions · 83 cleared · Since 2003
83
Total
83
Cleared
0
Denied

Asahi Intecc Co., Ltd. — FDA 510(k) Submissions

Asahi Intecc Co., Ltd. has submitted 83 FDA 510(k) premarket notifications since 2003, of which 83 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wire, Guide, Catheter, Catheter, Percutaneous, Guide, Wire, Catheter, Neurovasculature, Catheter, Percutaneous, Neurovasculature, Catheter, Intravascular, Diagnostic . Use the specialty filter in the sidebar to narrow results.

83 devices
1–25 of 83
CHIKAI Nexus petit
K252011 · MOF Guide, Wire, Catheter,... · Neurology
Feb 2026 220d
Branchor X Balloon Guide Catheter
K251240 · QJP Catheter, Percutaneous,... · Neurology
Jun 2025 59d
FUBUKI XF-R Neurovascular Long Sheath
K251560 · QJP Catheter, Percutaneous,... · Neurology
Jun 2025 30d
CHIKAI Nexus 014
K243383 · MOF Guide, Wire, Catheter,... · Neurology
Apr 2025 172d
SION blue PLUS
K243733 · DQX Wire, Guide, Catheter · Cardiovascular
Apr 2025 119d
Crossloop
K241962 · DQX Wire, Guide, Catheter · Cardiovascular
Mar 2025 267d
CROSSLEAD 0.018inch
K242597 · DQX Wire, Guide, Catheter · Cardiovascular
Mar 2025 187d
CROSSLEAD 0.014inch
K241702 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2025 238d
Tornus ES
K241801 · FGE Stents, Drains And... · Gastroenterology & Urology
Dec 2024 179d
CROSSLEAD Tracker
K241510 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2024 77d
ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3
K241158 · DQY Catheter, Percutaneous · Cardiovascular
Jun 2024 60d
MINAMO blue; MINAMO viola
K240387 · DQX Wire, Guide, Catheter · Cardiovascular
Jun 2024 134d
CROSSLEAD Penetration Peripheral Guide Wire
K230377 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2023 157d
Branchor Balloon Guide Catheter
K221951 · QJP Catheter, Percutaneous,... · Neurology
Oct 2022 98d
ASAHI Gladius Mongo18 PV ES
K213868 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2022 270d
CROSSLEAD Peripheral Guide Wire
K213315 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2022 270d
FUBUKI XF Neurovascular Long Sheath
K213589 · QJP Catheter, Percutaneous,... · Neurology
Mar 2022 132d
Branchor Balloon Guide Catheter
K203723 · QJP Catheter, Percutaneous,... · Neurology
Dec 2021 354d
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
K211898 · DQX Wire, Guide, Catheter · Cardiovascular
Dec 2021 170d
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),
K202252 · DQY Catheter, Percutaneous · Cardiovascular
Sep 2020 29d
ASAHI PTCA Guide Wire ASAHI Gaia Next
K192599 · DQX Wire, Guide, Catheter · Cardiovascular
Jan 2020 104d
ASAHI CROSSWALK Peripheral Support Catheter
K192782 · DQY Catheter, Percutaneous · Cardiovascular
Nov 2019 60d
Asahi PTCA Guide Wire Asahi SION Series
K191464 · DQX Wire, Guide, Catheter · Cardiovascular
Nov 2019 171d
MINAMO
K190176 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2019 181d
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
K191714 · MOF Guide, Wire, Catheter,... · Neurology
Jul 2019 30d

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