Cleared Traditional

K142265 - ONE Snare Endovascular Microsnare System

K142265 is the FDA 510(k) clearance for ONE Snare Endovascular Microsnare System by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 K142265.
Indy OTW Vascular Retriever
K160593 · Cook Incorporated · Sep 2016
Recovery Cone Removal System
K152136 · C.R. Bard, Inc. · Feb 2016
EN Snare Endovascular Snare System
K151497 · Merit Medical Systems, Inc. · Jul 2015
MERIT ONE SNARE SYSTEM
K122088 · Merit Medical Systems, Inc. · Dec 2012
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · Cook, Inc. · Nov 2011
EN SNARE ENDOVASCULAR SNARE SYSTEM
K092343 · Merit Medical Systems, Inc. · Aug 2009