Cleared Traditional

K153703 - Guiding Catheter

K153703 is an FDA 510(k) clearance for Guiding Catheter, manufactured by Texasmedical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K153703 · Texasmedical Technologies, Inc. · Cardiovascular device
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May 2016
Decision
141d
Days
Class 2
Risk

K153703 is an FDA 510(k) clearance for the Guiding Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Texasmedical Technologies, Inc. (El Paso, US). The FDA issued a Cleared decision on May 12, 2016 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 - K153703

510(k) Number K153703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date May 12, 2016
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 651
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K153703.
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K152401 · Boston Scientific Corporation · Dec 2015