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 Cordis Corp., Boston Scientific Corp and Asahi Intecc Co., Ltd..

764
Total
764
Cleared
116d
Avg days
1976
Since
764 devices
169–192 of 764
Cleared Oct 01, 1993
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466
C.R. Bard, Inc.
Cardiovascular · 77d
Cleared Aug 20, 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 269d
Cleared Apr 07, 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091
Cordis Corp.
Cardiovascular · 89d
Cleared Mar 01, 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074
C.R. Bard, Inc.
Cardiovascular · 145d
Cleared Feb 12, 1993
CORDIS STEERABLE GUIDEWIRE
K925833
Cordis Corp.
Cardiovascular · 88d
Cleared Feb 03, 1993
CORDIS VIERA GUIDEWIRE
K923696
Cordis Corp.
Cardiovascular · 195d
Cleared Oct 26, 1992
CORDIS STEERABLE GUIDEWIRE
K923134
Cordis Corp.
Cardiovascular · 119d
Cleared Sep 23, 1992
BAXTER SENSOR CORONARY GUIDEWIRE
K923240
Baxter Healthcare Corp
Cardiovascular · 83d
Cleared Jul 24, 1992
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
K922302
Boston Scientific Corp
Cardiovascular · 70d
Cleared Feb 27, 1992
DESERET GUIDEWIRE INTRODUCER
K915496
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 80d
Cleared Dec 18, 1991
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863
Cordis Corp.
Cardiovascular · 50d
Cleared Mar 01, 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423
Cordis Corp.
Cardiovascular · 87d
Cleared Dec 03, 1990
CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
K902612
Cordis Corp.
Cardiovascular · 173d
Cleared Nov 21, 1990
USCI(R) SILK (TM) GUIDE WIRE
K903923
C.R. Bard, Inc.
Cardiovascular · 89d
Cleared Feb 22, 1990
CRAGG CONVERTIBLE WIRE
K897152
Boston Scientific Corp
Cardiovascular · 58d
Cleared Oct 17, 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633
Cordis Corp.
Cardiovascular · 85d
Cleared Aug 17, 1989
USCI PROBE LINX EXTENSION WIRE
K890404
C.R. Bard, Inc.
Cardiovascular · 205d
Cleared Jun 20, 1989
USCI GREY/BLACK GUIDE WIRE
K890505
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Jan 12, 1989
USCI ADJUSTABLE TIP GUIDE WIRE
K884647
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Dec 27, 1988
BUCHBINDER MULTIFLEX GUIDEWIRE
K884274
Medtronic Vascular
Cardiovascular · 76d
Cleared Mar 22, 1988
CORDIS STEERABLE GUIDEWIRE
K873403
Cordis Corp.
Cardiovascular · 211d
Cleared Dec 27, 1983
OPEN END SPRING GUIDE
K832607
C.R. Bard, Inc.
Cardiovascular · 146d
Cleared Jul 24, 1979
PERVENOUS LEAD INTRODUCER SYSTEM
K791276
Cordis Corp.
Cardiovascular · 15d
Cleared Feb 23, 1979
MOVABLE CORE SAFETY GUIDE
K790258
Cordis Corp.
Cardiovascular · 17d