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
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 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 11, 1986
SNAP-ON TORQUER
Advanced Cardiovascular Systems, Inc.
Cardiovascular
16d
Cleared
Jun 09, 1986
SCHNEIDER-SHILEY WIRE TORQUER
Shiley, Inc.
Cardiovascular
41d
Cleared
May 30, 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
23d
Cleared
May 28, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
30d
Cleared
May 20, 1986
TELEFLEX TEFLON COATED GUIDEWIRE
Teleflexmedical, Inc.
Cardiovascular
116d
Cleared
Apr 28, 1986
GUIDE WIRE INTRODUCER
Target Therapeutics
Cardiovascular
55d
Cleared
Apr 23, 1986
GUIDED WIRE TORQUER
Target Therapeutics
Cardiovascular
50d
Cleared
Mar 31, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
Advanced Cardiovascular Systems, Inc.
Cardiovascular
118d
Cleared
Mar 31, 1986
(.O38) HI-TORQUE GUIDE WIRES
Target Therapeutics
Cardiovascular
47d
Cleared
Feb 18, 1986
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
Dlp, Inc.
Cardiovascular
60d
Cleared
Feb 10, 1986
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
Electro-Catheter Corp.
Cardiovascular
90d
Cleared
Nov 05, 1985
GUIDE WIRE
Target Therapeutics
Cardiovascular
36d