Cleared Traditional

K091825 - HI-TORQUE PROGRESS GUIDE WIRE FAMILY

K091825 is the FDA 510(k) clearance for HI-TORQUE PROGRESS GUIDE WIRE FAMILY by Abbott Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K091825 · Abbott Vascular, Inc. · Cardiovascular device
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Sep 2009
Decision
98d
Days
Class 2
Risk

K091825 is an FDA 510(k) clearance for the HI-TORQUE PROGRESS GUIDE WIRE FAMILY. 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 September 25, 2009 after a review of 98 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, Inc. devices

Submission Details

510(k) Number K091825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2009
Decision Date September 25, 2009
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 K091825.
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
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