Cleared Traditional

K103101 - HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

K103101 is an FDA 510(k) clearance for HI-TORQUE BALANCE MIDDLEWEIGHT ELITE, manufactured by Abbott Vascular-Cardiac Therapies. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K103101 · Abbott Vascular-Cardiac Therapies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
113d
Days
Class 2
Risk

K103101 is an FDA 510(k) clearance for the HI-TORQUE BALANCE MIDDLEWEIGHT ELITE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Vascular-Cardiac Therapies (Temecula, US). The FDA issued a Cleared decision on February 10, 2011 after a review of 113 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 Abbott Vascular-Cardiac Therapies devices

FDA 510(k) Submission Details - K103101

510(k) Number K103101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2010
Decision Date February 10, 2011
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 682
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K103101.
ASAHI GUIDE WIRE EXTENSION 165CM
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APPROACH PRO ST WIRE GUIDE
K110163 · Cook Incorporated · Feb 2011
ENDOLOGIX GUIDEWIRE
K110241 · Techdevice Corporation · Feb 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K110009 · Cook, Inc. · Feb 2011
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
K102818 · Micrus Endovascular Corporation · Dec 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
K103057 · Asahi Intecc Co., Ltd. · Nov 2010