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
433–456 of 766
Cleared May 21, 1997
CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID
K964551
Scimed Life Systems, Inc.
Cardiovascular · 189d
Cleared May 20, 1997
LOCKING STYLET 2
K970690
Cook Pacemaker Corp.
Cardiovascular · 84d
Cleared May 09, 1997
HANNIBAL GUIDEWIRE
K970494
Schneider (Europe) GmbH
Cardiovascular · 88d
Cleared Mar 28, 1997
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
K970244
Scimed Life Systems, Inc.
Cardiovascular · 65d
Cleared Mar 04, 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Feb 21, 1997
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)
K962765
Cordis Corp.
Cardiovascular · 220d
Cleared Jan 28, 1997
TORQUE DEVICE
K964352
B.Braun Medical, Inc.
Cardiovascular · 88d
Cleared Jan 28, 1997
TRANSEND GUIDEWIRE
K964611
Boston Scientific Corp
Cardiovascular · 71d
Cleared Jan 22, 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
K963702
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Dec 17, 1996
HYDRO-SELECT GUIDEWIRE
K954642
Microvena Corp.
Cardiovascular · 434d
Cleared Dec 17, 1996
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
K962572
Scimed Life Systems, Inc.
Cardiovascular · 169d
Cleared Dec 03, 1996
TFX MEDICAL GUIDEWIRE
K963320
Tfx Medical Group
Cardiovascular · 102d
Cleared Nov 20, 1996
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
K961917
Medtronics Interventional Vascular
Cardiovascular · 187d
Cleared Nov 13, 1996
CORDIS ST STEERABLE GUIDEWIRE
K963214
Cordis Corp.
Cardiovascular · 89d
Cleared Nov 07, 1996
CINCH QR SGW EXTENSION
K963171
Cordis Corp.
Cardiovascular · 85d
Cleared Oct 25, 1996
CORDIS STABILIZER PLUS XS
K962932
Cordis Corp.
Cardiovascular · 88d
Cleared Oct 01, 1996
B. BRAUN GUIDEWIRES
K961107
B.Braun Medical, Inc.
Cardiovascular · 195d
Cleared Sep 10, 1996
0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
K962266
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Jul 31, 1996
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
K961777
Cardio Metrics, Inc.
Cardiovascular · 85d
Cleared Jul 09, 1996
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K961445
Terumo Medical Corp.
Cardiovascular · 84d
Cleared Jun 27, 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271
C.R. Bard, Inc.
Cardiovascular · 86d
Cleared Jun 26, 1996
0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP
K961232
Biocompatibles , Ltd.
Cardiovascular · 89d
Cleared May 23, 1996
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
K960755
Medtronic Cardiac Surgery, Medtronic, Inc.
Cardiovascular · 90d
Cleared May 21, 1996
LRM
K960718
Lake Region Mfg., Inc.
Cardiovascular · 90d