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 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
Apr 16, 1986
ANGIOMED GUIED WIRES
Angiomed U.S., Inc.
Cardiovascular
128d
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
Cleared
Sep 17, 1985
TELEFLEX GUIDEWIRE
Teleflexmedical, Inc.
Cardiovascular
208d
Cleared
Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
Advanced Cardiovascular Systems, Inc.
Cardiovascular
56d
Cleared
Jun 26, 1985
GUIDE, WIRE, ANGIOGRAPHIC
Lake Region Mfg., Inc.
Cardiovascular
121d
Cleared
Jun 26, 1985
WIRE, GUIDE - MODIFICATION
Lake Region Mfg., Inc.
Cardiovascular
121d
Cleared
Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
Advanced Cardiovascular Systems, Inc.
Cardiovascular
63d
Cleared
Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
Advanced Cardiovascular Systems, Inc.
Cardiovascular
35d
Cleared
Feb 08, 1985
BIOPATCH BOVINE PERICARDIAL PATCH
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular
351d
Cleared
Jan 02, 1985
HYDROGLIDE SPRING GUIDE WIRES
Argon Medical Corp.
Cardiovascular
237d
Cleared
Nov 29, 1984
WIREGUIDE OR GUIDEWIRE
Medi-Tech, Inc.
Cardiovascular
121d
Cleared
Feb 13, 1984
CARDIOVASCULAR SPRING GUIDE WIRE
Mallinckrodt Critical Care
Cardiovascular
69d
Cleared
Dec 27, 1983
OPEN END SPRING GUIDE
C.R. Bard, Inc.
Cardiovascular
146d