Cleared Special

K151497 - EN Snare Endovascular Snare System

K151497 is the FDA 510(k) clearance for EN Snare Endovascular Snare System by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code MMX) cleared through the Special 510(k) pathway after a 27-day FDA review.

K151497 · Merit Medical Systems, Inc. · Cardiovascular device
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Jul 2015
Decision
27d
Days
Class 2
Risk

K151497 is an FDA 510(k) clearance for the EN Snare Endovascular Snare System. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Galway, IE). The FDA issued a Cleared decision on July 1, 2015 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K151497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2015
Decision Date July 01, 2015
Days to Decision 27 days
Submission Type Special
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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - MMX Device, Percutaneous Retrieval

All 19
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K151497.
Expro Elite Snare, Sympro Elite Snare
K163307 · Vascular Solutions, Inc. · Mar 2017
Indy OTW Vascular Retriever
K160593 · Cook Incorporated · Sep 2016
Recovery Cone Removal System
K152136 · C.R. Bard, Inc. · Feb 2016
ONE Snare Endovascular Microsnare System
K142265 · Merit Medical Systems, Inc. · Nov 2014
MERIT ONE SNARE SYSTEM
K122088 · Merit Medical Systems, Inc. · Dec 2012
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · Cook, Inc. · Nov 2011