Cleared Traditional

K072460 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

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

K072460 · Abbott Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K072460

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
Combination Product No
PCCP Authorized No
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.

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 681
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