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
Aug 22, 1994
MS AMPLATZ EXTRA STIFF GUIDE WIRE
Meadox Surgimed, Inc.
Cardiovascular
95d
Cleared
Aug 18, 1994
CARDIOMETRICS DUALFLOW SWITCH BOX
Cardio Metrics, Inc.
Cardiovascular
170d
Cleared
Jul 18, 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
80d
Cleared
Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
Boston Scientific Corp
Cardiovascular
184d
Cleared
May 31, 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES
Cardio Metrics, Inc.
Cardiovascular
64d
Cleared
May 24, 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
Scimed Life Systems, Inc.
Cardiovascular
36d
Cleared
May 12, 1994
ONTRAC STEERABLE GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
58d
Cleared
Mar 31, 1994
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS
Lake Region Mfg., Inc.
Cardiovascular
155d
Cleared
Mar 15, 1994
TORQUE DEVICE
Merit Medical Systems, Inc.
Cardiovascular
88d
Cleared
Mar 10, 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
Scimed Life Systems, Inc.
Cardiovascular
90d
Cleared
Feb 24, 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
Cordis Corp.
Cardiovascular
364d
Cleared
Feb 14, 1994
SCIMED ENTRE II PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
88d
Cleared
Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
Boston Scientific Corp
Cardiovascular
202d
Cleared
Jan 18, 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
Scimed Life Systems, Inc.
Cardiovascular
90d
Cleared
Dec 16, 1993
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
83d
Cleared
Dec 09, 1993
LOC GUIDE WIRE EXTENSION
Advanced Cardiovascular Systems, Inc.
Cardiovascular
93d
Cleared
Oct 15, 1993
AUTOMATIC PULL BACK DEVICE
Cardiovascular Imaging Systems, Inc.
Cardiovascular
87d
Cleared
Oct 01, 1993
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
C.R. Bard, Inc.
Cardiovascular
77d
Cleared
Aug 20, 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular
269d
Cleared
Aug 19, 1993
ARROW BLOOD CONTAINMENT DEVICE
Arrow Intl., Inc.
Cardiovascular
344d
Cleared
Aug 15, 1993
NEW HYDROPHILIC COATING FOR WIRE GUIDES
Arrow Intl., Inc.
Cardiovascular
356d
Cleared
Jul 14, 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
Peripheral Systems Group
Cardiovascular
120d
Cleared
Jul 09, 1993
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
Advanced Surgical, Inc.
Cardiovascular
143d
Cleared
Jun 25, 1993
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
Scimed Life Systems, Inc.
Cardiovascular
91d