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FDA 510(k)

Gatekeeper Balloon Catheter

K-Number: K192786 · 2020-04-25

ApplicantArch Catheter, LLC
Decision Date2020-04-25
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gatekeeper Balloon Catheter is a medical device manufactured by Arch Catheter, LLC. It received FDA 510(k) clearance on 2020-04-25 under approval number K192786. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gatekeeper Balloon Catheter?

Gatekeeper Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-04-25. It is manufactured by Arch Catheter, LLC. The 510(k) number is K192786.

When was Gatekeeper Balloon Catheter approved by the FDA?

Gatekeeper Balloon Catheter received FDA 510(k) clearance on 2020-04-25, under approval number K192786.

What company makes Gatekeeper Balloon Catheter?

Gatekeeper Balloon Catheter is manufactured by Arch Catheter, LLC.

What is the FDA product code for Gatekeeper Balloon Catheter?

The FDA product code for Gatekeeper Balloon Catheter is MJN.

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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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