Cleared Traditional

K091582 - GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15

K091582 is an FDA 510(k) clearance for GTX GUIDEWIRE, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K091582 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
185d
Days
Class 2
Risk

K091582 is an FDA 510(k) clearance for the GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on December 4, 2009 after a review of 185 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K091582

510(k) Number K091582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date December 04, 2009
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
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 K091582.
TRAILRUNNER GUIDEWIRES
K092965 · Lake Region Mfg., Inc. · Feb 2010
TRAXCESS DOCKING WIRE
K093647 · MicroVention, Inc. · Feb 2010
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
K093397 · MicroVention, Inc. · Dec 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303 · Merit Medical Systems, Inc. · Oct 2009
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
K091825 · Abbott Vascular, Inc. · Sep 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · Cook, Inc. · Aug 2009