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
Apr 06, 1989
KATZEN THROMBOLYSIS GUIDEWIRE
Medi-Tech, Inc.
Cardiovascular
205d
Cleared
Mar 31, 1989
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
Advanced Cardiovascular Systems, Inc.
Cardiovascular
287d
Cleared
Feb 06, 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
76d
Cleared
Jan 17, 1989
INTRODUCER SAFETY SYRINGE
Arrow Intl., Inc.
Cardiovascular
83d
Cleared
Jan 12, 1989
USCI ADJUSTABLE TIP GUIDE WIRE
C.R. Bard, Inc.
Cardiovascular
66d
Cleared
Dec 27, 1988
BUCHBINDER MULTIFLEX GUIDEWIRE
Medtronic Vascular
Cardiovascular
76d
Cleared
Dec 21, 1988
ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
71d
Cleared
Dec 13, 1988
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE
Target Therapeutics
Cardiovascular
68d
Cleared
Nov 04, 1988
CORONARY GUIDE WIRE
Datascope Corp.
Cardiovascular
74d
Cleared
Sep 27, 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
81d
Cleared
Aug 30, 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
Advanced Cardiovascular Systems, Inc.
Cardiovascular
85d
Cleared
Aug 19, 1988
COATING FOR WIRE GUIDE
Cook, Inc.
Cardiovascular
178d
Cleared
Aug 19, 1988
TAPER-22 STEERABLE GUIDEWIRE
Target Therapeutics
Cardiovascular
176d
Cleared
Aug 19, 1988
TAPER FLEX-TIP STEERABLE GUIDEWIRE
Target Therapeutics
Cardiovascular
176d
Cleared
Aug 03, 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
Advanced Cardiovascular Systems, Inc.
Cardiovascular
89d
Cleared
Jul 28, 1988
MEDRAD OPEN ENDED GUIDEWIRE
Medrad, Inc.
Cardiovascular
184d
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
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