Cleared Special

K173795 - HI-TORQUE TurnTrac Guide Wire Family

K173795 is the FDA 510(k) clearance for HI-TORQUE TurnTrac Guide Wire Family by Abbott Vascular. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K173795 · Abbott Vascular · Cardiovascular device
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Jan 2018
Decision
29d
Days
Class 2
Risk

K173795 is an FDA 510(k) clearance for the HI-TORQUE TurnTrac Guide Wire Family. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on January 12, 2018 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Vascular devices

Submission Details

510(k) Number K173795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2017
Decision Date January 12, 2018
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 499
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K173795.
Warrior 14 guidewire
K180128 · Vascular Solutions, Inc. · Feb 2018
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
K171933 · Asahi Intecc Co., Ltd. · Feb 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
K173235 · Scientia Vascular, LLC · Jan 2018
Amplatz Support Wire Guide with Apex Curve
K171445 · Cook Incorporated · Jan 2018
Roadrunner Extra Support Wire Guide
K171948 · Cook Incorporated · Jan 2018
Raider Guidewire
K173532 · Vascular Solutions, Inc. · Dec 2017