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 Aug 30, 1999
ENDOSONICS TRAK BACK DEVICE
K990271
Endosonics Corp.
Cardiovascular · 214d
Cleared Jul 23, 1999
PVS 1400 GUIDEWIRE
K990823
Precision Vascular Systems, Inc.
Cardiovascular · 133d
Cleared Jun 16, 1999
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
K991898
Microvena Corp.
Cardiovascular · 12d
Cleared May 05, 1999
MODIFICATION TO ULTRA-SELECT GUIDEWIRE
K991194
Microvena Corp.
Cardiovascular · 27d
Cleared Apr 29, 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152
Guidant Corp.
Cardiovascular · 23d
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 Feb 03, 1999
PRESSUREWIRE SENSOR, MODEL #12001
K983506
Radi Medical Systems AB
Cardiovascular · 119d
Cleared Feb 01, 1999
GUIDEWIRE
K982559
Galt Medical Corp.
Cardiovascular · 193d
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 27, 1998
PIOLAX HYDROPHILIC GUIDEWIRE
K980977
Piolax Medical Devices, Inc.
Cardiovascular · 225d
Cleared Oct 21, 1998
DOCKING-EXTENSION WIRE
K982592
Schneider (Europe) GmbH
Cardiovascular · 89d
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