Cleared Traditional

K093647 - TRAXCESS DOCKING WIRE

K093647 is an FDA 510(k) clearance for TRAXCESS DOCKING WIRE, manufactured by MicroVention, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K093647 · MicroVention, Inc. · Cardiovascular device
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Feb 2010
Decision
91d
Days
Class 2
Risk

K093647 is an FDA 510(k) clearance for the TRAXCESS DOCKING WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on February 24, 2010 after a review of 91 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 MicroVention, Inc. devices

FDA 510(k) Submission Details - K093647

510(k) Number K093647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2009
Decision Date February 24, 2010
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 663
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K093647.
GTX 12 GIDEWIRE
K100470 · Medtronic, Inc. · Apr 2010
NEUROSCOUT STEERABLE GUIDEWIRE
K100351 · Codman & Shurtleff, Inc. · Mar 2010
TRAILRUNNER GUIDEWIRES
K092965 · Lake Region Mfg., Inc. · Feb 2010
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
K093397 · MicroVention, Inc. · Dec 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582 · Medtronic Vascular · Dec 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303 · Merit Medical Systems, Inc. · Oct 2009