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
577–600 of 766
Cleared Sep 06, 1991
SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE
K912156
Schneider Intl., Ltd.
Cardiovascular · 115d
Cleared Jul 05, 1991
MAGNUM-MEIER RECANALIZATION GUIDEWIRE
K911547
Schneider Intl., Ltd.
Cardiovascular · 88d
Cleared Jun 25, 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared May 16, 1991
TORQUE DEVICE FOR A GUIDE WIRE
K910969
Terumo Corp.
Cardiovascular · 71d
Cleared Apr 19, 1991
ULTRA-SELECT PTCA GUIDEWIRE
K910280
Microvena Corp.
Cardiovascular · 86d
Cleared Mar 01, 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423
Cordis Corp.
Cardiovascular · 87d
Cleared Feb 25, 1991
QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE
K904582
Meadox Surgimed, Inc.
Cardiovascular · 139d
Cleared Feb 25, 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548
Mallinckrodt Medical
Cardiovascular · 76d
Cleared Feb 20, 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639
Lake Region Mfg., Inc.
Cardiovascular · 65d
Cleared Feb 19, 1991
SILICONE COATED GUIDEWIRES
K905581
Lake Region Mfg., Inc.
Cardiovascular · 69d
Cleared Feb 04, 1991
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
K905502
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Jan 30, 1991
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K905432
Datascope Corp.
Cardiovascular · 57d
Cleared Dec 06, 1990
GUIDEWIRE
K904477
Datascope Corp.
Cardiovascular · 66d
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 Sep 27, 1990
ROADRUNNER WIRE GUIDE
K901899
Cook, Inc.
Cardiovascular · 153d
Cleared Sep 04, 1990
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
K902755
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 74d
Cleared Aug 08, 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
K902207
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 84d
Cleared Jun 21, 1990
DATASCOPE SLIDEWIRE(TM)
K901347
Datascope Corp.
Cardiovascular · 90d
Cleared Jun 12, 1990
ACS ADVANCED CONCEPT GUIDE WIRE
K900386
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 134d
Cleared Jun 11, 1990
INSITE STEERABLE GUIDEWIRE
K901224
Lake Region Mfg., Inc.
Cardiovascular · 89d
Cleared May 23, 1990
FLEXMEDICS GUIDEWIRE .012 ONLY
K895899
Flexmedics
Cardiovascular · 229d
Cleared Feb 22, 1990
CRAGG CONVERTIBLE WIRE
K897152
Boston Scientific Corp
Cardiovascular · 58d
Cleared Feb 02, 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d