Cleared Traditional

K173052 - Heraeus TMW Guidewire

K173052 is an FDA 510(k) clearance for Heraeus TMW Guidewire, manufactured by Heraeus Medical Components, LLC. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K173052 · Heraeus Medical Components, LLC · Cardiovascular device
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Oct 2017
Decision
22d
Days
Class 2
Risk

K173052 is an FDA 510(k) clearance for the Heraeus TMW Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Heraeus Medical Components, LLC (Plymouth, US). The FDA issued a Cleared decision on October 20, 2017 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heraeus Medical Components, LLC devices

FDA 510(k) Submission Details - K173052

510(k) Number K173052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date October 20, 2017
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 684
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K173052.
TXM Hydrophilic Guidewire
K170915 · Texasmedical Technologies, Inc. · Nov 2017
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
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K172453 · Boston Scientific Corporation · Nov 2017
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K170417 · Terumo Corporation · Sep 2017
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K171897 · Cook Incorporated · Aug 2017