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
385–408 of 766
Cleared Jul 24, 1992
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
K922302
Boston Scientific Corp
Cardiovascular · 70d
Cleared Jul 23, 1992
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
K922410
Scimed Life Systems, Inc.
Cardiovascular · 63d
Cleared Jun 09, 1992
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
K914194
Scimed Life Systems, Inc.
Cardiovascular · 265d
Cleared Jun 09, 1992
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
K915723
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 172d
Cleared May 20, 1992
GUIDE WIRES, MODIFICATION
K914986
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared Feb 27, 1992
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
K914531
Arrow Intl., Inc.
Cardiovascular · 139d
Cleared Feb 27, 1992
DESERET GUIDEWIRE INTRODUCER
K915496
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 80d
Cleared Feb 14, 1992
GUIDER DASHER
K915115
Target Therapeutics
Cardiovascular · 93d
Cleared Feb 11, 1992
GUIDER, DASHER
K914030
Target Therapeutics
Cardiovascular · 154d
Cleared Feb 11, 1992
GUIDER-22
K914031
Target Therapeutics
Cardiovascular · 154d
Cleared Feb 11, 1992
NITINOL SEEKER(R) GUIDE WIRES
K914032
Target Therapeutics
Cardiovascular · 154d
Cleared Feb 11, 1992
GUIDE WIRE EXTENSION
K915114
Target Therapeutics
Cardiovascular · 90d
Cleared Jan 08, 1992
010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF
K914828
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Dec 18, 1991
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863
Cordis Corp.
Cardiovascular · 50d
Cleared Dec 13, 1991
ONTRAC
K914138
Lake Region Mfg., Inc.
Cardiovascular · 88d
Cleared Dec 05, 1991
REMOVE LABELING RESTRICT FROM GUIDE WIRES
K912293
Target Therapeutics
Cardiovascular · 196d
Cleared Nov 05, 1991
0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE
K913074
Terumo Medical Corp.
Cardiovascular · 117d
Cleared Oct 28, 1991
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE
K913631
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 74d
Cleared Oct 23, 1991
.010 HI-TORQUE PLUS(TM) GUIDE WIRE
K913328
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Oct 23, 1991
VASCULAR GUIDE WIRE
K913353
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 89d
Cleared Oct 08, 1991
ACS VSW GUIDE WIRE
K913178
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Sep 23, 1991
AMPLANTZ AND BENTSON GUIDEWIRES
K912798
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 90d
Cleared Sep 11, 1991
OPEN ENDED GUIDEWIRE
K912878
Lake Region Mfg., Inc.
Cardiovascular · 72d
Cleared Jun 25, 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d