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
457–480 of 766
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 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 11, 1986
SNAP-ON TORQUER
K862409
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 16d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY WIRE TORQUER
K861606
Shiley, Inc.
Cardiovascular · 41d
Cleared May 30, 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 23d
Cleared May 28, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
K861574
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared May 20, 1986
TELEFLEX TEFLON COATED GUIDEWIRE
K860258
Teleflexmedical, Inc.
Cardiovascular · 116d
Cleared Apr 28, 1986
GUIDE WIRE INTRODUCER
K860841
Target Therapeutics
Cardiovascular · 55d
Cleared Apr 23, 1986
GUIDED WIRE TORQUER
K860840
Target Therapeutics
Cardiovascular · 50d
Cleared Mar 31, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 118d
Cleared Mar 31, 1986
(.O38) HI-TORQUE GUIDE WIRES
K860533
Target Therapeutics
Cardiovascular · 47d
Cleared Feb 18, 1986
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
K855089
Dlp, Inc.
Cardiovascular · 60d
Cleared Feb 10, 1986
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
K854511
Electro-Catheter Corp.
Cardiovascular · 90d
Cleared Nov 05, 1985
GUIDE WIRE
K853999
Target Therapeutics
Cardiovascular · 36d