FDA 510(k)

Gatekeeper Balloon Catheter

K-Number: K192786 · 2020-04-25

Decision Date2020-04-25

Product CodeMJN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Gatekeeper Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arch Catheter, LLC. It received FDA 510(k) clearance on 2020-04-25 under 510(k) 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. The listed applicant is Arch Catheter, LLC. The 510(k) number is K192786.

When did Gatekeeper Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Gatekeeper Balloon Catheter?

The FDA 510(k) record lists Arch Catheter, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gatekeeper Balloon Catheter?

The FDA product code for Gatekeeper Balloon Catheter is MJN.

Related Devices (Code: MJN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices K221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC K212324RenovoCathRenovorx, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.