FDA 510(k)

HI-TORQUE InfilTrac Guide Wire Family

K-Number: K193126 · 2019-12-11

Decision Date2019-12-11

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HI-TORQUE InfilTrac Guide Wire Family is a medical device manufactured by Abbott Vascular. It received FDA 510(k) clearance on 2019-12-11 under approval number K193126. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-TORQUE InfilTrac Guide Wire Family?

HI-TORQUE InfilTrac Guide Wire Family is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Abbott Vascular. The 510(k) number is K193126.

When was HI-TORQUE InfilTrac Guide Wire Family approved by the FDA?

HI-TORQUE InfilTrac Guide Wire Family received FDA 510(k) clearance on 2019-12-11, under approval number K193126.

What company makes HI-TORQUE InfilTrac Guide Wire Family?

HI-TORQUE InfilTrac Guide Wire Family is manufactured by Abbott Vascular.

What is the FDA product code for HI-TORQUE InfilTrac Guide Wire Family?

The FDA product code for HI-TORQUE InfilTrac Guide Wire Family is DQX.

Related Clinical Trials

NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING NCT00698607 Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing COMPLETED

Other Devices by Abbott Vascular

K161985Steerable Guide Catheter K172394Steerable Guide Catheter K172073Hi-Torque Command 18 Guide Wire K180040NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter K173795HI-TORQUE TurnTrac Guide Wire Family K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

View all 15 devices →

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.