Cleared Traditional

K072460 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSA...

K072460 is the FDA 510(k) clearance for HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSA... by Abbott Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K072460 · Abbott Vascular, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2008
Decision
224d
Days
Class 2
Risk

K072460 is an FDA 510(k) clearance for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Temecula, US). The FDA issued a Cleared decision on April 11, 2008 after a review of 224 days - an extended review cycle.

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 Abbott Vascular, Inc. devices

Submission Details

510(k) Number K072460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2007
Decision Date April 11, 2008
Days to Decision 224 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 125d · This submission: 224d
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 500
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K072460.
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · Boston Scientific Corp · Aug 2008
APPROACH CTO WIRE GUIDE
K081337 · Cook Incorporated · Aug 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863 · MicroVention, Inc. · Apr 2008
RUNTHROUGH NS EXTENSION WIRE
K080563 · Terumo Medical Corp. · Mar 2008
MANDREL GUIDEWIRES OR M-WIRES
K080144 · Lake Region Mfg., Inc. · Feb 2008
PEGASUS STEERABLE (PTCA) GUIDEWIRE
K073655 · Lake Region Mfg., Inc. · Jan 2008