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
361–384 of 766
Cleared Oct 01, 1993
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466
C.R. Bard, Inc.
Cardiovascular · 77d
Cleared Aug 20, 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 269d
Cleared Aug 19, 1993
ARROW BLOOD CONTAINMENT DEVICE
K924558
Arrow Intl., Inc.
Cardiovascular · 344d
Cleared Aug 15, 1993
NEW HYDROPHILIC COATING FOR WIRE GUIDES
K924385
Arrow Intl., Inc.
Cardiovascular · 356d
Cleared Jun 25, 1993
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
K931514
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Jun 10, 1993
TERUMO CORONARY GUIDE WIRE
K925852
Terumo Medical Corp.
Cardiovascular · 205d
Cleared Jun 04, 1993
DOC-TITE(TM) GUIDE WIRE EXTENSION
K931171
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d
Cleared May 26, 1993
CATHETER GUIDEWIRE (PERIPHERAL USE)
K930961
Target Therapeutics
Cardiovascular · 91d
Cleared Apr 29, 1993
AMPLATZ GUIDEWIRES
K930622
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 80d
Cleared Apr 08, 1993
SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR
K926457
Scimed Life Systems, Inc.
Cardiovascular · 105d
Cleared Apr 07, 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091
Cordis Corp.
Cardiovascular · 89d
Cleared Mar 01, 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074
C.R. Bard, Inc.
Cardiovascular · 145d
Cleared Feb 12, 1993
ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
K925381
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 112d
Cleared Feb 12, 1993
CORDIS STEERABLE GUIDEWIRE
K925833
Cordis Corp.
Cardiovascular · 88d
Cleared Feb 03, 1993
CORDIS VIERA GUIDEWIRE
K923696
Cordis Corp.
Cardiovascular · 195d
Cleared Dec 21, 1992
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891
Cook, Inc.
Cardiovascular · 301d
Cleared Dec 21, 1992
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 200d
Cleared Dec 08, 1992
TAPER GUIDEWIRES
K924987
Target Therapeutics
Cardiovascular · 55d
Cleared Nov 23, 1992
RADIFOCUS(R) (CATHETER) GUIDE WIRE
K924202
Terumo Medical Corp.
Cardiovascular · 95d
Cleared Nov 17, 1992
SEEKER LITE - 10
K922912
Target Therapeutics
Cardiovascular · 153d
Cleared Oct 26, 1992
CORDIS STEERABLE GUIDEWIRE
K923134
Cordis Corp.
Cardiovascular · 119d
Cleared Oct 16, 1992
ROADRUNNER RLTF GUIDE WIRE
K920824
Cook, Inc.
Cardiovascular · 235d
Cleared Sep 23, 1992
BAXTER SENSOR CORONARY GUIDEWIRE
K923240
Baxter Healthcare Corp
Cardiovascular · 83d
Cleared Sep 21, 1992
MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI
K921702
Merit Medical Systems, Inc.
Cardiovascular · 164d