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FDA 510(k)

FUBUKI XF Neurovascular Long Sheath

K-Number: K213589 · 2022-03-24

ApplicantAsahi Intecc Co., Ltd.
Decision Date2022-03-24
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUBUKI XF Neurovascular Long Sheath is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2022-03-24 under approval number K213589. 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 Neurovascular Long Sheath?

FUBUKI XF Neurovascular Long Sheath is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K213589.

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

FUBUKI XF Neurovascular Long Sheath received FDA 510(k) clearance on 2022-03-24, under approval number K213589.

What company makes FUBUKI XF Neurovascular Long Sheath?

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

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

The FDA product code for FUBUKI XF 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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