Cleared Traditional

K092343 - EN SNARE ENDOVASCULAR SNARE SYSTEM

K092343 is an FDA 510(k) clearance for EN SNARE ENDOVASCULAR SNARE 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 3-day FDA review.

K092343 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
3d
Days
Class 2
Risk

K092343 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. (South Jordan, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 3 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. 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K092343

510(k) Number K092343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date August 07, 2009
Days to Decision 3 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
122d faster than avg
Panel avg: 125d · This submission: 3d
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 24
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K092343.
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
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K021606 · Medical Device Technologies, Inc. · May 2002
IN-TIME RETRIEVAL DEVICE
K014109 · Boston Scientific, Target · Mar 2002