DQX · Class II · 21 CFR 870.1330

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
409–432 of 766
Cleared Apr 29, 1998
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
K980360
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Apr 24, 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
K972793
Radi Medical Systems AB
Cardiovascular · 270d
Cleared Apr 24, 1998
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K980294
Guidant Corp.
Cardiovascular · 87d
Cleared Mar 20, 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
K980119
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
K974773
Guidant Corp.
Cardiovascular · 81d
Cleared Jan 12, 1998
LUGE GUIDE WIRE
K973945
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 05, 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845
Cordis Corp.
Cardiovascular · 89d
Cleared Dec 19, 1997
RADIAL AND FEMORAL ARTERY CATHETER
K971086
B.Braun Medical, Inc.
Cardiovascular · 269d
Cleared Dec 19, 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708
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
K973494
Guidant Corp.
Cardiovascular · 88d
Cleared Dec 11, 1997
IVT 0.014 PTFE-COATED TRACKWIRE
K971688
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
K970938
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 249d
Cleared Nov 03, 1997
THEROX INFUSION GUIDEWIRES
K971719
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
K972944
Medtronics Interventional Vascular
Cardiovascular · 84d
Cleared Oct 14, 1997
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
K972762
Cardio Metrics, Inc.
Cardiovascular · 82d
Cleared Oct 09, 1997
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
K971281
Medcomp
Cardiovascular · 185d
Cleared Sep 17, 1997
ACS HI-TORQUE RULER GUIDE WIRE
K972290
Guidant Corp.
Cardiovascular · 90d
Cleared Aug 25, 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
K972142
Guidant Corp.
Cardiovascular · 80d
Cleared Aug 18, 1997
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
K965140
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
K971395
Target Therapeutics
Neurology · 90d
Cleared Jul 09, 1997
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
K971815
Guidant Corp.
Cardiovascular · 54d
Cleared Jul 01, 1997
TRANSEND EX PLATINUM GUIDEWIRE
K971254
Boston Scientific Corp
Cardiovascular · 89d
Cleared Jun 10, 1997
CLYDE CORONARY GUIDEWIRE
K970528
Schneider (Europe) GmbH
Cardiovascular · 119d
Cleared Jun 06, 1997
PTCA GUIDEWIRE
K970376
Lake Region Mfg., Inc.
Cardiovascular · 123d