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FDA 510(k)

Branchor Balloon Guide Catheter

K-Number: K203723 · 2021-12-10

ApplicantAsahi Intecc Co., Ltd.
Decision Date2021-12-10
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Branchor Balloon Guide Catheter is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2021-12-10 under approval number K203723. 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 Balloon Guide Catheter?

Branchor Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K203723.

When was Branchor Balloon Guide Catheter approved by the FDA?

Branchor Balloon Guide Catheter received FDA 510(k) clearance on 2021-12-10, under approval number K203723.

What company makes Branchor Balloon Guide Catheter?

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

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

The FDA product code for Branchor 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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