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
313–336 of 766
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 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 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 Nov 07, 1995
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760
Cordis Corp.
Cardiovascular · 88d
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 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 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
Cleared Jun 05, 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379
Boston Scientific Corp
Cardiovascular · 215d
Cleared Jun 02, 1995
NAVIGUIDE HYDROPHILIC GUIDE WIRE
K943358
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 325d
Cleared May 25, 1995
SCIMED CHOICE PT PTCA GUIDE WIRE
K950835
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared May 15, 1995
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
K950752
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Apr 28, 1995
PRECEDER GUIDEWIRE
K950352
Boston Scientific Corp
Cardiovascular · 88d
Cleared Apr 28, 1995
SCIMED SCEPTOR PTCA GUIDE WIRE
K950534
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 28, 1995
SCIMED SCEPTOR EXCHANGE GUIDE WIRE
K950535
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 14, 1995
SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE
K950266
Scimed Life Systems, Inc.
Cardiovascular · 81d
Cleared Apr 14, 1995
CORDIS STEERABLE GUIDEWIRES
K950316
Cordis Corp.
Cardiovascular · 78d
Cleared Apr 12, 1995
DASHER-14
K950069
Target Therapeutics
Cardiovascular · 93d
Cleared Apr 05, 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
K950156
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d