FDA Product Code DQX: Wire, Guide, Catheter
FDA product code DQX covers catheter guidewires used in intravascular procedures.
These thin, flexible wires are inserted into blood vessels to guide catheters, sheaths, and other devices to their target location. They are available in a wide range of diameters, stiffness profiles, and tip shapes optimized for different anatomical access points and clinical applications.
DQX devices are Class II medical devices, regulated under 21 CFR 870.1330 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Asahi Intecc Co., Ltd., Advanced Cardiovascular Systems, Inc. and Lake Region Mfg., Inc..
766
Total
766
Cleared
116d
Avg days
1976
Since
766 devices
Cleared
Apr 29, 1998
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
Scimed Life Systems, Inc.
Cardiovascular
90d
Cleared
Apr 24, 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
Radi Medical Systems AB
Cardiovascular
270d
Cleared
Apr 24, 1998
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
Guidant Corp.
Cardiovascular
87d
Cleared
Mar 20, 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
Guidant Corp.
Cardiovascular
66d
Cleared
Mar 13, 1998
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC
Guidant Corp.
Cardiovascular
81d
Cleared
Jan 12, 1998
LUGE GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
88d
Cleared
Jan 05, 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
Cordis Corp.
Cardiovascular
89d
Cleared
Dec 19, 1997
RADIAL AND FEMORAL ARTERY CATHETER
B.Braun Medical, Inc.
Cardiovascular
269d
Cleared
Dec 19, 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
Merit Medical Systems, Inc.
Cardiovascular
81d
Cleared
Dec 12, 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG
Guidant Corp.
Cardiovascular
88d
Cleared
Dec 11, 1997
IVT 0.014 PTFE-COATED TRACKWIRE
Boston Scientific /International Technologies
Cardiovascular
218d
Cleared
Nov 17, 1997
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING
Biocompatibles Cardiovascular, Inc.
Cardiovascular
249d
Cleared
Nov 03, 1997
THEROX INFUSION GUIDEWIRES
Therox, Inc.
Cardiovascular
178d
Cleared
Nov 03, 1997
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
Medtronics Interventional Vascular
Cardiovascular
84d
Cleared
Oct 14, 1997
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
Cardio Metrics, Inc.
Cardiovascular
82d
Cleared
Oct 09, 1997
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
Medcomp
Cardiovascular
185d
Cleared
Sep 17, 1997
ACS HI-TORQUE RULER GUIDE WIRE
Guidant Corp.
Cardiovascular
90d
Cleared
Aug 25, 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
Guidant Corp.
Cardiovascular
80d
Cleared
Aug 18, 1997
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
Cardio Metrics, Inc.
Cardiovascular
238d
Cleared
Jul 14, 1997
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE
Target Therapeutics
Neurology
90d
Cleared
Jul 09, 1997
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
Guidant Corp.
Cardiovascular
54d
Cleared
Jul 01, 1997
TRANSEND EX PLATINUM GUIDEWIRE
Boston Scientific Corp
Cardiovascular
89d
Cleared
Jun 10, 1997
CLYDE CORONARY GUIDEWIRE
Schneider (Europe) GmbH
Cardiovascular
119d
Cleared
Jun 06, 1997
PTCA GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
123d