Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

84 results for "Asahi Intecc Co., Ltd."
1–24 of 84
Search insights Median review: 114d Cleared: 100% Top manufacturer: Asahi Intecc Co., Ltd. Lead specialty: Cardiovascular
Cleared May 11, 2026
SAYA 86 Radial Access Guide Catheter
K254178 · QJP
Asahi Intecc Co., Ltd.
Neurology · 139d
Cleared Feb 02, 2026
CHIKAI Nexus petit
K252011 · MOF
Asahi Intecc Co., Ltd.
Neurology · 220d
Cleared Jun 20, 2025
FUBUKI XF-R Neurovascular Long Sheath
K251560 · QJP
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jun 20, 2025
Branchor X Balloon Guide Catheter
K251240 · QJP
Asahi Intecc Co., Ltd.
Neurology · 59d
Cleared Apr 21, 2025
CHIKAI Nexus 014
K243383 · MOF
Asahi Intecc Co., Ltd.
Neurology · 172d
Cleared Apr 02, 2025
SION blue PLUS
K243733 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 119d
Cleared Mar 27, 2025
Crossloop
K241962 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 267d
Cleared Mar 05, 2025
CROSSLEAD 0.018inch
K242597 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 187d
Cleared Feb 06, 2025
CROSSLEAD 0.014inch
K241702 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Dec 17, 2024
Tornus ES
K241801 · FGE
Asahi Intecc Co., Ltd.
Gastroenterology & Urology · 179d
Cleared Aug 14, 2024
CROSSLEAD Tracker
K241510 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 77d
Cleared Jun 25, 2024
ASAHI Veloute
K241158 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Jun 21, 2024
MINAMO blue
K240387 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 134d
Cleared Jul 20, 2023
CROSSLEAD Penetration Peripheral Guide Wire
K230377 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 157d
Cleared Oct 11, 2022
Branchor Balloon Guide Catheter
K221951 · QJP
Asahi Intecc Co., Ltd.
Neurology · 98d
Cleared Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
K213868 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
K213315 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
K213589 · QJP
Asahi Intecc Co., Ltd.
Neurology · 132d
Cleared Dec 10, 2021
Branchor Balloon Guide Catheter
K203723 · QJP
Asahi Intecc Co., Ltd.
Neurology · 354d
Cleared CT Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
K211898 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 170d
Cleared Sep 08, 2020
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair...
K202252 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Jan 02, 2020
ASAHI PTCA Guide Wire ASAHI Gaia Next
K192599 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 104d
Cleared Nov 29, 2019
ASAHI CROSSWALK Peripheral Support Catheter
K192782 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Nov 21, 2019
Asahi PTCA Guide Wire Asahi SION Series
K191464 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 171d