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FDA 510(k)

GORE Molding and Occlusion Balloon Catheter

K-Number: K172567 · 2018-01-31

ApplicantW. L. Gore and Associates, Inc.
Decision Date2018-01-31
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE Molding and Occlusion Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K172567. 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 GORE Molding and Occlusion Balloon Catheter?

GORE Molding and Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is W. L. Gore and Associates, Inc.. The 510(k) number is K172567.

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

GORE Molding and Occlusion Balloon Catheter received FDA 510(k) clearance on 2018-01-31, under 510(k) number K172567.

Who is the listed applicant for GORE Molding and Occlusion Balloon Catheter?

The FDA 510(k) record lists W. L. Gore and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE Molding and Occlusion Balloon Catheter?

The FDA product code for GORE Molding and 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 W. L. Gore and Associates, Inc. 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.

PMA P200030SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK222919GORE® ENFORM BiomaterialK180919GORE Tri-Lumen 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

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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