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
Mar 01, 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
Cordis Corp.
Cardiovascular
87d
Cleared
Feb 25, 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
Mallinckrodt Medical
Cardiovascular
76d
Cleared
Feb 20, 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
65d
Cleared
Feb 19, 1991
SILICONE COATED GUIDEWIRES
Lake Region Mfg., Inc.
Cardiovascular
69d
Cleared
Feb 04, 1991
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
Advanced Cardiovascular Systems, Inc.
Cardiovascular
59d
Cleared
Jan 30, 1991
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
Datascope Corp.
Cardiovascular
57d
Cleared
Dec 06, 1990
GUIDEWIRE
Datascope Corp.
Cardiovascular
66d
Cleared
Dec 03, 1990
CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
Cordis Corp.
Cardiovascular
173d
Cleared
Nov 21, 1990
USCI(R) SILK (TM) GUIDE WIRE
C.R. Bard, Inc.
Cardiovascular
89d
Cleared
Sep 27, 1990
ROADRUNNER WIRE GUIDE
Cook, Inc.
Cardiovascular
153d
Cleared
Sep 04, 1990
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
Advanced Cardiovascular Systems, Inc.
Cardiovascular
74d
Cleared
Aug 08, 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
84d
Cleared
Jun 21, 1990
DATASCOPE SLIDEWIRE(TM)
Datascope Corp.
Cardiovascular
90d
Cleared
Jun 12, 1990
ACS ADVANCED CONCEPT GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
134d
Cleared
Jun 11, 1990
INSITE STEERABLE GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
89d
Cleared
Feb 22, 1990
CRAGG CONVERTIBLE WIRE
Boston Scientific Corp
Cardiovascular
58d
Cleared
Feb 02, 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
88d
Cleared
Nov 01, 1989
DATASCOPE STEERING HANDLE
Datascope Corp.
Cardiovascular
90d
Cleared
Oct 17, 1989
CORDIS STEERABLE COATED GUIDEWIRE
Cordis Corp.
Cardiovascular
85d
Cleared
Oct 12, 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
Datascope Corp.
Cardiovascular
90d
Cleared
Aug 17, 1989
USCI PROBE LINX EXTENSION WIRE
C.R. Bard, Inc.
Cardiovascular
205d
Cleared
Jun 20, 1989
USCI GREY/BLACK GUIDE WIRE
C.R. Bard, Inc.
Cardiovascular
139d
Cleared
Jun 20, 1989
GUIDE WIRE INTRODUCER
Datascope Corp.
Cardiovascular
124d
Cleared
May 31, 1989
INTERVENTIONAL PRODUCTS - GUIDE WIRES
E-Z-Em, Inc.
Cardiovascular
134d