FDA.report

510(k) K251560

Device
FUBUKI XF-R Neurovascular Long Sheath
Applicant
Asahi Intecc Co., Ltd.
510(k) number
K251560
Product code
QJP
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-20
Date received
2025-05-21
Regulation
870.1250
Classification name
Catheter, Percutaneous, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Fujimura Katsuhiko
Address
3-100 Akatsuki-Cho Seto JP 489-0071 489-0071

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K251097V-DAC CatheterVesalio, Inc.2026-01-06
K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc.2026-01-05
K252213Bendit17 MicrocatheterBend IT Technologies, Ltd.2025-12-03
K251372VersaD Delivery CatheterUnity Medical, Inc.2025-10-24
K252569Carrier XL Delivery CatheterBalt USA, LLC2025-10-22
K250960DUO MicrocatheterRev Neuro, LLC2025-09-08
K251240Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd.2025-06-20
K25104493 NeuFlex CatheterPiraeus Medical2025-05-23