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
625–648 of 766
Cleared Jul 25, 1988
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
K881787
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Apr 28, 1988
ACS HI-TORQUE GUIDE WIRES
K874202
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 196d
Cleared Apr 01, 1988
GUIDE WIRE INTRODUCER
K873972
Target Therapeutics
Cardiovascular · 185d
Cleared Mar 22, 1988
CORDIS STEERABLE GUIDEWIRE
K873403
Cordis Corp.
Cardiovascular · 211d
Cleared Mar 07, 1988
TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
K874542
Toray Industries (America), Inc.
Cardiovascular · 125d
Cleared Feb 17, 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Jan 27, 1988
TELEFLEX STEERABLE GUIDEWIRE
K871850
Teleflexmedical, Inc.
Cardiovascular · 260d
Cleared Dec 03, 1987
STUBBIE STEERABLE GUIDEWIRE
K873543
Target Therapeutics
Cardiovascular · 93d
Cleared Nov 30, 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517
Olympus Corp.
Cardiovascular · 224d
Cleared Sep 15, 1987
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)
K871882
Lake Region Mfg., Inc.
Cardiovascular · 127d
Cleared Aug 21, 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared Jul 16, 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
K871137
Dlp, Inc.
Cardiovascular · 118d
Cleared Mar 25, 1987
GUIDE WIRE
K870664
Datascope Corp.
Cardiovascular · 34d
Cleared Mar 20, 1987
TARGET THERAPEUTICS TAPER GUIDE WIRE
K864316
Target Therapeutics
Cardiovascular · 137d
Cleared Feb 19, 1987
AMPLATZ MOVEABLE CORE GUIDEWIRE
K864058
Lake Region Mfg., Inc.
Cardiovascular · 122d
Cleared Feb 19, 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787
Shiley, Inc.
Cardiovascular · 73d
Cleared Dec 05, 1986
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 18d
Cleared Nov 20, 1986
TERUMO RADIFOCUS GUIDE WIRE
K863138
Terumo Medical Corp.
Cardiovascular · 97d
Cleared Sep 19, 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983
Target Therapeutics
Cardiovascular · 43d
Cleared Sep 19, 1986
UMI STEERABLE TORQUE GUIDE WIRE
K863178
Universal Medical Instrument Corp.
Cardiovascular · 32d
Cleared Sep 11, 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Sep 04, 1986
ACS WIRE SHAPER
K862567
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Jul 18, 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
K860430
Meadox Surgimed, Inc.
Cardiovascular · 164d
Cleared Jul 11, 1986
TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE
K861115
Toray Industries (America), Inc.
Cardiovascular · 108d