Cleared Traditional

K092965 - TRAILRUNNER GUIDEWIRES

K092965 is an FDA 510(k) clearance for TRAILRUNNER GUIDEWIRES, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K092965 · Lake Region Mfg., Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2010
Decision
154d
Days
Class 2
Risk

K092965 is an FDA 510(k) clearance for the TRAILRUNNER GUIDEWIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on February 26, 2010 after a review of 154 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K092965

510(k) Number K092965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2009
Decision Date February 26, 2010
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K092965.
ROLL-X GUIDEWIRE
K100710 · St Jude Medical · Apr 2010
GTX 12 GIDEWIRE
K100470 · Medtronic, Inc. · Apr 2010
NEUROSCOUT STEERABLE GUIDEWIRE
K100351 · Codman & Shurtleff, Inc. · Mar 2010
TRAXCESS DOCKING WIRE
K093647 · MicroVention, Inc. · Feb 2010
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