Cleared Traditional

K170915 - TXM Hydrophilic Guidewire

K170915 is an FDA 510(k) clearance for TXM Hydrophilic Guidewire, manufactured by Texasmedical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K170915 · Texasmedical Technologies, Inc. · Cardiovascular device
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Nov 2017
Decision
238d
Days
Class 2
Risk

K170915 is an FDA 510(k) clearance for the TXM Hydrophilic Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Texasmedical Technologies, Inc. (El Paso, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 238 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 Texasmedical Technologies, Inc. devices

FDA 510(k) Submission Details - K170915

510(k) Number K170915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2017
Decision Date November 21, 2017
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
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 590
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K170915.
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