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
649–672 of 766
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 Apr 16, 1986
ANGIOMED GUIED WIRES
K854912
Angiomed U.S., Inc.
Cardiovascular · 128d
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
Cleared Sep 17, 1985
TELEFLEX GUIDEWIRE
K850677
Teleflexmedical, Inc.
Cardiovascular · 208d
Cleared Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Jun 26, 1985
GUIDE, WIRE, ANGIOGRAPHIC
K850827
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE - MODIFICATION
K850828
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 35d
Cleared Feb 08, 1985
BIOPATCH BOVINE PERICARDIAL PATCH
K840756
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 351d
Cleared Jan 02, 1985
HYDROGLIDE SPRING GUIDE WIRES
K841926
Argon Medical Corp.
Cardiovascular · 237d
Cleared Nov 29, 1984
WIREGUIDE OR GUIDEWIRE
K843012
Medi-Tech, Inc.
Cardiovascular · 121d
Cleared Feb 13, 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223
Mallinckrodt Critical Care
Cardiovascular · 69d
Cleared Dec 27, 1983
OPEN END SPRING GUIDE
K832607
C.R. Bard, Inc.
Cardiovascular · 146d