Cleared Traditional

K113454 - 14 WIRE STANDARD, 14 WIRE LS

K113454 is an FDA 510(k) clearance for 14 WIRE STANDARD, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K113454

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.

DQX Device Classification - Class 2, Special Controls

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 643
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
HI TORQUE CONNECT GUIDEWIRE
K112381 · Lake Region Medical · Nov 2011
VSI GUIDEWIRE
K112631 · Vascular Solutions, Inc. · Oct 2011