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
Oct 09, 1997
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
Medcomp
Cardiovascular
185d
Cleared
Sep 17, 1997
ACS HI-TORQUE RULER GUIDE WIRE
Guidant Corp.
Cardiovascular
90d
Cleared
Aug 25, 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
Guidant Corp.
Cardiovascular
80d
Cleared
Jul 14, 1997
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE
Target Therapeutics
Neurology
90d
Cleared
Jul 09, 1997
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
Guidant Corp.
Cardiovascular
54d
Cleared
Jul 01, 1997
TRANSEND EX PLATINUM GUIDEWIRE
Boston Scientific Corp
Cardiovascular
89d
Cleared
Jun 06, 1997
PTCA GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
123d
Cleared
May 21, 1997
CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID
Scimed Life Systems, Inc.
Cardiovascular
189d
Cleared
May 20, 1997
LOCKING STYLET 2
Cook Pacemaker Corp.
Cardiovascular
84d
Cleared
Mar 28, 1997
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
Scimed Life Systems, Inc.
Cardiovascular
65d
Cleared
Mar 04, 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
78d
Cleared
Feb 21, 1997
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)
Cordis Corp.
Cardiovascular
220d
Cleared
Jan 28, 1997
TORQUE DEVICE
B.Braun Medical, Inc.
Cardiovascular
88d
Cleared
Jan 28, 1997
TRANSEND GUIDEWIRE
Boston Scientific Corp
Cardiovascular
71d
Cleared
Jan 22, 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
128d
Cleared
Dec 17, 1996
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
169d
Cleared
Nov 13, 1996
CORDIS ST STEERABLE GUIDEWIRE
Cordis Corp.
Cardiovascular
89d
Cleared
Nov 07, 1996
CINCH QR SGW EXTENSION
Cordis Corp.
Cardiovascular
85d
Cleared
Oct 25, 1996
CORDIS STABILIZER PLUS XS
Cordis Corp.
Cardiovascular
88d
Cleared
Oct 01, 1996
B. BRAUN GUIDEWIRES
B.Braun Medical, Inc.
Cardiovascular
195d
Cleared
Jul 09, 1996
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
Terumo Medical Corp.
Cardiovascular
84d
Cleared
Jun 27, 1996
USCI COMMANDER SERIES GUIDE WIRES
C.R. Bard, Inc.
Cardiovascular
86d
Cleared
May 21, 1996
LRM
Lake Region Mfg., Inc.
Cardiovascular
90d
Cleared
May 15, 1996
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
63d