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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 a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under approval 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. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K251560.

When was FUBUKI XF-R Neurovascular Long Sheath approved by the FDA?

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

What company makes FUBUKI XF-R Neurovascular Long Sheath?

FUBUKI XF-R Neurovascular Long Sheath is manufactured by Asahi Intecc Co., Ltd..

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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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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