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FDA 510(k)

FUBUKI XF-R Neurovascular Long Sheath

K-Number: K251560 · 2025-06-20

ApplicantAsahi Intecc Co., Ltd.
Decision Date2025-06-20
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUBUKI XF-R Neurovascular Long Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K251560. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUBUKI XF-R Neurovascular Long Sheath?

FUBUKI XF-R Neurovascular Long Sheath is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K251560.

When did FUBUKI XF-R Neurovascular Long Sheath receive FDA 510(k) clearance?

FUBUKI XF-R Neurovascular Long Sheath received FDA 510(k) clearance on 2025-06-20, under 510(k) number K251560.

Who is the listed applicant for FUBUKI XF-R Neurovascular Long Sheath?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUBUKI XF-R Neurovascular Long Sheath?

The FDA product code for FUBUKI XF-R Neurovascular Long Sheath is QJP.

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Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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