Cleared Traditional

K113454 - 14 WIRE STANDARD

K113454 is the FDA 510(k) clearance for 14 WIRE STANDARD by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K113454 · Micro Therapeutics, Inc. · Cardiovascular device
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Feb 2012
Decision
95d
Days
Class 2
Risk

K113454 is an FDA 510(k) clearance for the 14 WIRE STANDARD, 14 WIRE LS. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K113454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date February 24, 2012
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 444
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K113454.
MERIT HYDROPHILIC GUIDE WIRE
K120644 · Merit Medical Systems, Inc. · Sep 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · Codman & Shurtleff, Inc. · Aug 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · Covidien, LLC · Apr 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
K113716 · Asahi Intecc Co., Ltd. · Feb 2012
VSI GUIDEWIRE
K112631 · Vascular Solutions, Inc. · Oct 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745 · Boston Scientific Corporation · Oct 2011