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FDA 510(k)

Branchor X Balloon Guide Catheter

K-Number: K251240 · 2025-06-20

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

Device Summary

Branchor X Balloon Guide Catheter is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under approval number K251240. 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 Branchor X Balloon Guide Catheter?

Branchor X Balloon Guide Catheter 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 K251240.

When was Branchor X Balloon Guide Catheter approved by the FDA?

Branchor X Balloon Guide Catheter received FDA 510(k) clearance on 2025-06-20, under approval number K251240.

What company makes Branchor X Balloon Guide Catheter?

Branchor X Balloon Guide Catheter is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for Branchor X Balloon Guide Catheter?

The FDA product code for Branchor X Balloon Guide Catheter is QJP.

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Related Devices (Code: 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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