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
457–480 of 766
Cleared May 16, 1996
CRICKET
K955304
Microvena Corp.
Cardiovascular · 178d
Cleared May 15, 1996
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
K961015
Scimed Life Systems, Inc.
Cardiovascular · 63d
Cleared Apr 29, 1996
RAILWIRE
K954552
Boston Scientific /International Technologies
Cardiovascular · 210d
Cleared Apr 29, 1996
IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK
K954622
Boston Scientific /International Technologies
Cardiovascular · 207d
Cleared Apr 29, 1996
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
K960563
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 29, 1996
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657
Scimed Life Systems, Inc.
Cardiovascular · 73d
Cleared Apr 09, 1996
0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING
K955135
Biocompatibles , Ltd.
Cardiovascular · 152d
Cleared Apr 05, 1996
ACS ANCHOR EXCHANGE DEVICE
K955175
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 144d
Cleared Mar 11, 1996
ESSENCE GUIDEWIRE
K955637
Cordis Neurovascular, Inc.
Cardiovascular · 91d
Cleared Feb 28, 1996
CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404
K955551
Cardio Metrics, Inc.
Cardiovascular · 85d
Cleared Feb 02, 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801
Terumo Medical Corp.
Cardiovascular · 42d
Cleared Dec 22, 1995
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
K943896
Datascope Corp.
Cardiovascular · 499d
Cleared Dec 13, 1995
THE NINER NITINOL GUIDEWIRE
K952860
Microvena Corp.
Cardiovascular · 174d
Cleared Nov 07, 1995
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760
Cordis Corp.
Cardiovascular · 88d
Cleared Nov 07, 1995
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)
K954913
Cardio Metrics, Inc.
Cardiovascular · 35d
Cleared Oct 18, 1995
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K953533
Terumo Medical Corp.
Cardiovascular · 83d
Cleared Sep 21, 1995
PRECEDER GUIDEWIRE
K953023
Boston Scientific Corp
Cardiovascular · 84d
Cleared Aug 29, 1995
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE
K952562
Cardio Metrics, Inc.
Cardiovascular · 88d
Cleared Aug 18, 1995
FINESSE GUIDEWIRE CORONARY
K952430
Flexmedics
Cardiovascular · 86d
Cleared Jul 20, 1995
CORDIS STEERABLE GUIDEWIRE
K952067
Cordis Corp.
Cardiovascular · 79d
Cleared Jul 10, 1995
URESIL(R) GUIDEWIRE
K945934
Uresil Corp.
Cardiovascular · 217d
Cleared Jun 27, 1995
FLEXFINDER GUIDEWIRE
K943390
Flexmedics
Cardiovascular · 348d
Cleared Jun 22, 1995
SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE
K950216
Scimed Life Systems, Inc.
Cardiovascular · 154d
Cleared Jun 22, 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307
Baxter Healthcare Corp
Cardiovascular · 92d