DQX · Class II · 21 CFR 870.1330

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
337–360 of 766
Cleared Mar 31, 1995
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE
K946240
Scimed Life Systems, Inc.
Cardiovascular · 99d
Cleared Mar 31, 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
K950113
Scimed Life Systems, Inc.
Cardiovascular · 79d
Cleared Mar 31, 1995
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
K950141
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Mar 17, 1995
SCIMED(R) ENTRE PTCA GUIDE WIRE
K946180
Scimed Life Systems, Inc.
Cardiovascular · 87d
Cleared Mar 03, 1995
SCIMED CHIOCE PLUS PTCA GUIDE WIRE
K945129
Scimed Life Systems, Inc.
Cardiovascular · 135d
Cleared Feb 24, 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
K946029
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Dec 30, 1994
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
K945159
Scimed Life Systems, Inc.
Cardiovascular · 70d
Cleared Dec 19, 1994
THE PROMPT GUIDWIRE
K943522
Cordis Corp.
Cardiovascular · 154d
Cleared Dec 08, 1994
GUIDE WIRE
K942453
Boston Scientific Corp
Cardiovascular · 199d
Cleared Sep 16, 1994
CORDIS STEERABLE GUIDEWIRE
K943340
Cordis Corp.
Cardiovascular · 66d
Cleared Aug 31, 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333
Scimed Life Systems, Inc.
Cardiovascular · 107d
Cleared Jul 18, 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997
Boston Scientific Corp
Cardiovascular · 184d
Cleared May 24, 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895
Scimed Life Systems, Inc.
Cardiovascular · 36d
Cleared May 12, 1994
ONTRAC STEERABLE GUIDEWIRE
K941229
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared Mar 31, 1994
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS
K935170
Lake Region Mfg., Inc.
Cardiovascular · 155d
Cleared Mar 15, 1994
TORQUE DEVICE
K936032
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Mar 10, 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Feb 24, 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
K930982
Cordis Corp.
Cardiovascular · 364d
Cleared Feb 14, 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
K933334
Boston Scientific Corp
Cardiovascular · 202d
Cleared Jan 18, 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022
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
K934602
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Dec 09, 1993
LOC GUIDE WIRE EXTENSION
K934339
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 93d