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 25, 1988
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
90d
Cleared
Apr 28, 1988
ACS HI-TORQUE GUIDE WIRES
Advanced Cardiovascular Systems, Inc.
Cardiovascular
196d
Cleared
Apr 01, 1988
GUIDE WIRE INTRODUCER
Target Therapeutics
Cardiovascular
185d
Cleared
Mar 22, 1988
CORDIS STEERABLE GUIDEWIRE
Cordis Corp.
Cardiovascular
211d
Cleared
Mar 07, 1988
TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
Toray Industries (America), Inc.
Cardiovascular
125d
Cleared
Feb 17, 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
Advanced Cardiovascular Systems, Inc.
Cardiovascular
90d
Cleared
Jan 27, 1988
TELEFLEX STEERABLE GUIDEWIRE
Teleflexmedical, Inc.
Cardiovascular
260d
Cleared
Dec 03, 1987
STUBBIE STEERABLE GUIDEWIRE
Target Therapeutics
Cardiovascular
93d
Cleared
Nov 30, 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
Olympus Corp.
Cardiovascular
224d
Cleared
Sep 15, 1987
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)
Lake Region Mfg., Inc.
Cardiovascular
127d
Cleared
Aug 21, 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
Advanced Cardiovascular Systems, Inc.
Cardiovascular
73d
Cleared
Jul 16, 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
Dlp, Inc.
Cardiovascular
118d
Cleared
Mar 25, 1987
GUIDE WIRE
Datascope Corp.
Cardiovascular
34d
Cleared
Mar 20, 1987
TARGET THERAPEUTICS TAPER GUIDE WIRE
Target Therapeutics
Cardiovascular
137d
Cleared
Feb 19, 1987
AMPLATZ MOVEABLE CORE GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
122d
Cleared
Feb 19, 1987
SCHNEIDER-SHILEY GUIDE WIRE
Shiley, Inc.
Cardiovascular
73d
Cleared
Dec 05, 1986
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
Advanced Cardiovascular Systems, Inc.
Cardiovascular
18d
Cleared
Nov 20, 1986
TERUMO RADIFOCUS GUIDE WIRE
Terumo Medical Corp.
Cardiovascular
97d
Cleared
Sep 19, 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
Target Therapeutics
Cardiovascular
43d
Cleared
Sep 19, 1986
UMI STEERABLE TORQUE GUIDE WIRE
Universal Medical Instrument Corp.
Cardiovascular
32d
Cleared
Sep 11, 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
80d
Cleared
Sep 04, 1986
ACS WIRE SHAPER
Advanced Cardiovascular Systems, Inc.
Cardiovascular
59d
Cleared
Jul 18, 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
Meadox Surgimed, Inc.
Cardiovascular
164d
Cleared
Jul 11, 1986
TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE
Toray Industries (America), Inc.
Cardiovascular
108d