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
265–288 of 766
Cleared Mar 25, 1999
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
K990639
Guidant Corp.
Cardiovascular · 27d
Cleared Mar 23, 1999
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF
K983346
Guidant Corp.
Cardiovascular · 181d
Cleared Mar 08, 1999
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
K984394
Guidant Corp.
Cardiovascular · 90d
Cleared Jan 08, 1999
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018
K982272
Biotronik, Inc.
Cardiovascular · 193d
Cleared Dec 11, 1998
SILVERSTREAK HYDROPHILIC GUIDEWIRE
K982543
Micro Therapeutics, Inc.
Cardiovascular · 143d
Cleared Nov 12, 1998
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241
Scimed Life Systems, Inc.
Cardiovascular · 365d
Cleared Nov 12, 1998
STRATEGY CORONARY WIRE GUIDE
K983771
Cook, Inc.
Cardiovascular · 17d
Cleared Nov 10, 1998
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876
Guidant Corp.
Cardiovascular · 88d
Cleared Nov 10, 1998
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
K983033
Guidant Corp.
Cardiovascular · 71d
Cleared Oct 14, 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713
C.R. Bard, Inc.
Cardiovascular · 301d
Cleared Sep 11, 1998
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K982083
Guidant Corp.
Cardiovascular · 88d
Cleared Jul 22, 1998
CORE AND COIL ASSEMBLY GUIDEWIRE
K971322
Lake Region Mfg., Inc.
Cardiovascular · 468d
Cleared Jul 15, 1998
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1
K981381
Guidant Corp.
Cardiovascular · 90d
Cleared Jul 10, 1998
LAKE REGION MANUFACTURING GUIDEWIRES
K981326
Lake Region Mfg., Inc.
Cardiovascular · 88d
Cleared May 11, 1998
CORDIS VANGUARD STEERABLE GUIDEWIRES
K974560
Cordis Corp.
Cardiovascular · 157d
Cleared Apr 29, 1998
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
K980360
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Apr 24, 1998
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K980294
Guidant Corp.
Cardiovascular · 87d
Cleared Mar 20, 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
K980119
Guidant Corp.
Cardiovascular · 66d
Cleared Mar 13, 1998
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC
K974773
Guidant Corp.
Cardiovascular · 81d
Cleared Jan 12, 1998
LUGE GUIDE WIRE
K973945
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 05, 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845
Cordis Corp.
Cardiovascular · 89d
Cleared Dec 19, 1997
RADIAL AND FEMORAL ARTERY CATHETER
K971086
B.Braun Medical, Inc.
Cardiovascular · 269d
Cleared Dec 19, 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708
Merit Medical Systems, Inc.
Cardiovascular · 81d
Cleared Dec 12, 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG
K973494
Guidant Corp.
Cardiovascular · 88d