Cleared Traditional

K172567 - GORE Molding and Occlusion Balloon Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172567 · W. L. Gore and Associates, Inc. · Cardiovascular device
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Jan 2018
Decision
159d
Days
Class 2
Risk

K172567 is an FDA 510(k) clearance for the GORE Molding and Occlusion Balloon Catheter. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by W. L. Gore and Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on January 31, 2018 after a review of 159 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all W. L. Gore and Associates, Inc. devices

Submission Details

510(k) Number K172567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2017
Decision Date January 31, 2018
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MJN Catheter, Intravascular Occluding, Temporary

All 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K172567.
pREBOA-PRO Catheter
K243795 · Prytime Medical Devices, Inc. · Sep 2025
Bridge Plus Occlusion Balloon (590-002)
K251358 · Philips Image Guided Therapy Devices · Jun 2025
preCARDIA Occlusion System
K221294 · Abiomed, Inc. · Jun 2023
LANDMARK REBOA Catheter
K214060 · Zien Medical Technologies, Inc. · Sep 2022
Fogarty Occlusion Catheter
K211610 · Edwards Lifesciences, LLC · Feb 2022
RenovoCath
K212324 · Renovorx, Inc. · Aug 2021