Cleared Traditional

K172567 - GORE Molding and Occlusion Balloon Catheter

K172567 is an FDA 510(k) clearance for GORE Molding and Occlusion Balloon Catheter, manufactured by W. L. Gore and Associates, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 159-day FDA review.

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

FDA 510(k) Submission Details - K172567

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
Combination Product No
PCCP Authorized No
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.

MJN Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K172567.
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