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 Cordis Corp., Boston Scientific Corp and Asahi Intecc Co., Ltd..

764
Total
764
Cleared
116d
Avg days
1976
Since
764 devices
145–168 of 764
Cleared Sep 09, 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237
Medtronic Vascular
Cardiovascular · 69d
Cleared Oct 14, 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713
C.R. Bard, Inc.
Cardiovascular · 301d
Cleared May 11, 1998
CORDIS VANGUARD STEERABLE GUIDEWIRES
K974560
Cordis Corp.
Cardiovascular · 157d
Cleared Jan 05, 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845
Cordis Corp.
Cardiovascular · 89d
Cleared Jul 01, 1997
TRANSEND EX PLATINUM GUIDEWIRE
K971254
Boston Scientific Corp
Cardiovascular · 89d
Cleared Feb 21, 1997
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)
K962765
Cordis Corp.
Cardiovascular · 220d
Cleared Jan 28, 1997
TRANSEND GUIDEWIRE
K964611
Boston Scientific Corp
Cardiovascular · 71d
Cleared Nov 13, 1996
CORDIS ST STEERABLE GUIDEWIRE
K963214
Cordis Corp.
Cardiovascular · 89d
Cleared Nov 07, 1996
CINCH QR SGW EXTENSION
K963171
Cordis Corp.
Cardiovascular · 85d
Cleared Oct 25, 1996
CORDIS STABILIZER PLUS XS
K962932
Cordis Corp.
Cardiovascular · 88d
Cleared Jun 27, 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271
C.R. Bard, Inc.
Cardiovascular · 86d
Cleared Nov 07, 1995
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760
Cordis Corp.
Cardiovascular · 88d
Cleared Sep 21, 1995
PRECEDER GUIDEWIRE
K953023
Boston Scientific Corp
Cardiovascular · 84d
Cleared Jul 20, 1995
CORDIS STEERABLE GUIDEWIRE
K952067
Cordis Corp.
Cardiovascular · 79d
Cleared Jun 22, 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307
Baxter Healthcare Corp
Cardiovascular · 92d
Cleared Jun 05, 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379
Boston Scientific Corp
Cardiovascular · 215d
Cleared Apr 28, 1995
PRECEDER GUIDEWIRE
K950352
Boston Scientific Corp
Cardiovascular · 88d
Cleared Apr 14, 1995
CORDIS STEERABLE GUIDEWIRES
K950316
Cordis Corp.
Cardiovascular · 78d
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 Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997
Boston Scientific Corp
Cardiovascular · 184d
Cleared Feb 24, 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
K930982
Cordis Corp.
Cardiovascular · 364d
Cleared Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
K933334
Boston Scientific Corp
Cardiovascular · 202d