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FDA 510(k)

Occlusion Balloon Catheter

K-Number: K183679 · 2019-04-24

ApplicantQxmedical, LLC
Decision Date2019-04-24
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Occlusion Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Qxmedical, LLC. It received FDA 510(k) clearance on 2019-04-24 under 510(k) number K183679. 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 Occlusion Balloon Catheter?

Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-04-24. The listed applicant is Qxmedical, LLC. The 510(k) number is K183679.

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

Occlusion Balloon Catheter received FDA 510(k) clearance on 2019-04-24, under 510(k) number K183679.

Who is the listed applicant for Occlusion Balloon Catheter?

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

What is the FDA product code for Occlusion Balloon Catheter?

The FDA product code for Occlusion Balloon Catheter is MJN.

Related Clinical Trials

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.

NCT06798753Occlusion Balloon vs. 5FR Ureteral CatheterCOMPLETEDNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Other records listing Qxmedical, LLC as applicant

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.

K200317Support CatheterK160561Boosting Catheter

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 DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, 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.

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