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
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
May 09, 1997
HANNIBAL GUIDEWIRE
Schneider (Europe) GmbH
Cardiovascular
88d
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
HYDRO-SELECT GUIDEWIRE
Microvena Corp.
Cardiovascular
434d
Cleared
Dec 17, 1996
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
169d
Cleared
Dec 03, 1996
TFX MEDICAL GUIDEWIRE
Tfx Medical Group
Cardiovascular
102d
Cleared
Nov 20, 1996
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
Medtronics Interventional Vascular
Cardiovascular
187d
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
Sep 10, 1996
0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
Biocompatibles Cardiovascular, Inc.
Cardiovascular
90d
Cleared
Jul 31, 1996
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
Cardio Metrics, Inc.
Cardiovascular
85d
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
Jun 26, 1996
0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP
Biocompatibles , Ltd.
Cardiovascular
89d
Cleared
May 23, 1996
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
Medtronic Cardiac Surgery, Medtronic, Inc.
Cardiovascular
90d
Cleared
May 21, 1996
LRM
Lake Region Mfg., Inc.
Cardiovascular
90d