Cleared Traditional

K152762 - Fogarty Occlusion Catheter

K152762 is an FDA 510(k) clearance for Fogarty Occlusion Catheter, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K152762 · Edwards Lifesciences, LLC · Cardiovascular device
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Nov 2015
Decision
60d
Days
Class 2
Risk

K152762 is an FDA 510(k) clearance for the Fogarty Occlusion Catheter. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 23, 2015 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K152762

510(k) Number K152762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2015
Decision Date November 23, 2015
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 K152762.
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EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · Boston Scientific Corp · Jul 2014
LEMAITRE 8F OCCLUSION CATHETER
K132022 · LeMaitre Vascular, Inc. · Nov 2013