Cleared Special

K152404 - Hi-Torque Command 18 Guide Wire

K152404 is an FDA 510(k) clearance for Hi-Torque Command 18 Guide Wire, manufactured by Abbott Vascular. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 27-day FDA review.

K152404 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
27d
Days
Class 2
Risk

K152404 is an FDA 510(k) clearance for the Hi-Torque Command 18 Guide Wire. 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 September 21, 2015 after a review of 27 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

FDA 510(k) Submission Details - K152404

510(k) Number K152404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2015
Decision Date September 21, 2015
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K152404.
R350 guidewire
K151234 · Vascular Solutions, Inc. · Nov 2015
Radifocus Glidewire
K152740 · Ashitaka Factory of Terumo Corp. · Nov 2015
HI-TORQUE BALANCE
K152709 · Abbott Vascular · Oct 2015
Medtronic Confida Brecker Guidewire
K150465 · Medtronic Core Valve, LLC · Aug 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · Asahi Intecc Co., Ltd. · Jun 2015
Opto Wire and OptoMonitor System
K142598 · Opsens, Inc. · Jun 2015