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
361–384 of 766
Cleared Jul 25, 2001
STREERABLE PTCA GUIDEWIRE
K011968
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared May 16, 2001
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K003084
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 10, 2001
MANDREL GUIDEWIRE ASSEMBLY
K011084
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Mar 22, 2001
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
K010497
Micro Therapeutics, Inc.
Cardiovascular · 29d
Cleared Mar 01, 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511
Cordis Neurovascular, Inc.
Cardiovascular · 8d
Cleared Jan 30, 2001
APPALEAD GW+03XXXXXXR SERIES
K003394
Nipro Medical Corp.
Cardiovascular · 90d
Cleared Dec 06, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
K003483
Lake Region Mfg., Inc.
Cardiovascular · 27d
Cleared Oct 04, 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289
Merit Medical Systems, Inc.
Cardiovascular · 69d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962
Radi Medical Systems AB
Cardiovascular · 12d
Cleared Aug 24, 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K002206
Guidant Corp.
Cardiovascular · 34d
Cleared Aug 03, 2000
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212
Micro Therapeutics, Inc.
Cardiovascular · 13d
Cleared Aug 02, 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736
Biotronik, Inc.
Cardiovascular · 56d
Cleared Jul 07, 2000
SNIPER, MODEL OR-3872XX SERIES
K001251
Nipro Medical Corp.
Cardiovascular · 79d
Cleared Jun 07, 2000
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
K001454
Micro Therapeutics, Inc.
Cardiovascular · 29d
Cleared May 12, 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
K001198
Datascope Corp.
Cardiovascular · 29d
Cleared Apr 14, 2000
AGILITY STEERABLE GUIDEWIRE
K001033
Cordis Neurovascular, Inc.
Cardiovascular · 14d
Cleared Mar 01, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE
K000011
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared Feb 16, 2000
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
K981936
Advanced Biomedical Devices, Inc.
Cardiovascular · 624d
Cleared Jan 13, 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358
Cordis Corp.
Cardiovascular · 17d
Cleared Nov 02, 1999
BARD HYDROPHILIC COATED GUIDE WIRES
K993000
C.R. Bard, Inc.
Cardiovascular · 56d
Cleared Oct 28, 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 122d
Cleared Oct 21, 1999
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
K993257
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Sep 23, 1999
AGILITY STEERABLE GUIDEWIRE
K991646
Cordis Neurovascular, Inc.
Cardiovascular · 133d
Cleared Sep 09, 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237
Medtronic Vascular
Cardiovascular · 69d