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
Jul 24, 1992
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
Boston Scientific Corp
Cardiovascular
70d
Cleared
Jul 23, 1992
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
Scimed Life Systems, Inc.
Cardiovascular
63d
Cleared
Jun 09, 1992
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
265d
Cleared
Jun 09, 1992
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
172d
Cleared
May 20, 1992
GUIDE WIRES, MODIFICATION
E-Z-Em, Inc.
Cardiovascular
209d
Cleared
Feb 27, 1992
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
Arrow Intl., Inc.
Cardiovascular
139d
Cleared
Feb 27, 1992
DESERET GUIDEWIRE INTRODUCER
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular
80d
Cleared
Feb 14, 1992
GUIDER DASHER
Target Therapeutics
Cardiovascular
93d
Cleared
Feb 11, 1992
GUIDER, DASHER
Target Therapeutics
Cardiovascular
154d
Cleared
Feb 11, 1992
GUIDER-22
Target Therapeutics
Cardiovascular
154d
Cleared
Feb 11, 1992
NITINOL SEEKER(R) GUIDE WIRES
Target Therapeutics
Cardiovascular
154d
Cleared
Feb 11, 1992
GUIDE WIRE EXTENSION
Target Therapeutics
Cardiovascular
90d
Cleared
Jan 08, 1992
010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF
Advanced Cardiovascular Systems, Inc.
Cardiovascular
76d
Cleared
Dec 18, 1991
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
Cordis Corp.
Cardiovascular
50d
Cleared
Dec 13, 1991
ONTRAC
Lake Region Mfg., Inc.
Cardiovascular
88d
Cleared
Dec 05, 1991
REMOVE LABELING RESTRICT FROM GUIDE WIRES
Target Therapeutics
Cardiovascular
196d
Cleared
Nov 05, 1991
0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE
Terumo Medical Corp.
Cardiovascular
117d
Cleared
Oct 28, 1991
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
74d
Cleared
Oct 23, 1991
.010 HI-TORQUE PLUS(TM) GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
90d
Cleared
Oct 23, 1991
VASCULAR GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
89d
Cleared
Oct 08, 1991
ACS VSW GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
83d
Cleared
Sep 23, 1991
AMPLANTZ AND BENTSON GUIDEWIRES
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular
90d
Cleared
Sep 11, 1991
OPEN ENDED GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
72d
Cleared
Jun 25, 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
Advanced Cardiovascular Systems, Inc.
Cardiovascular
83d