Cleared Special

K083738 - HI-TORQUE FLEX-T GUIDE WIRE

K083738 is an FDA 510(k) clearance for HI-TORQUE FLEX-T GUIDE WIRE, manufactured by Abbott Vascular. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 85-day FDA review.

K083738 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
85d
Days
Class 2
Risk

K083738 is an FDA 510(k) clearance for the HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on March 11, 2009 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Vascular devices

FDA 510(k) Submission Details - K083738

510(k) Number K083738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2008
Decision Date March 11, 2009
Days to Decision 85 days
Submission Type Special
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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K083738.
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · Cook, Inc. · Aug 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · Boston Scientific Corp · Jul 2009
THE MEDCOMP .010 VASCULAR GUIDEWIRES
K081775 · Medcomp · Mar 2009
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
K090274 · Micrus Endovascular Corporation · Mar 2009
TAD AND TAD II TAPERED GUIDE WIRES
K083732 · Abbott Vascular · Feb 2009
.035 LOC GUIDE WIRE EXTENSION
K083713 · Abbott Vascular · Feb 2009