Cleared Traditional

K142265 - ONE Snare Endovascular Microsnare System

K142265 is an FDA 510(k) clearance for ONE Snare Endovascular Microsnare System, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K142265 · Merit Medical Systems, Inc. · Cardiovascular device
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Nov 2014
Decision
90d
Days
Class 2
Risk

K142265 is an FDA 510(k) clearance for the ONE Snare Endovascular Microsnare 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 November 13, 2014 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K142265

510(k) Number K142265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2014
Decision Date November 13, 2014
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMX Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K142265.
Recovery Cone Removal System
K152136 · C.R. Bard, Inc. · Feb 2016
Bard Snare Retrieval Kit
K152560 · Neometrics, Inc. · Oct 2015
EN Snare Endovascular Snare System
K151497 · Merit Medical Systems, Inc. · Jul 2015
CRUX SNARE FILTER RETRIEVAL SET
K133681 · Volcano Corporation · Jan 2014
MERIT ONE SNARE SYSTEM
K122088 · Merit Medical Systems, Inc. · Dec 2012
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · Cook, Inc. · Nov 2011