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 31, 1995
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
99d
Cleared
Mar 31, 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
79d
Cleared
Mar 31, 1995
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
77d
Cleared
Mar 17, 1995
SCIMED(R) ENTRE PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
87d
Cleared
Mar 03, 1995
SCIMED CHIOCE PLUS PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
135d
Cleared
Feb 24, 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
Advanced Cardiovascular Systems, Inc.
Cardiovascular
77d
Cleared
Dec 30, 1994
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
70d
Cleared
Dec 19, 1994
THE PROMPT GUIDWIRE
Cordis Corp.
Cardiovascular
154d
Cleared
Dec 08, 1994
GUIDE WIRE
Boston Scientific Corp
Cardiovascular
199d
Cleared
Sep 16, 1994
CORDIS STEERABLE GUIDEWIRE
Cordis Corp.
Cardiovascular
66d
Cleared
Aug 31, 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
Scimed Life Systems, Inc.
Cardiovascular
107d
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 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