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
505–528 of 766
Cleared Aug 22, 1994
MS AMPLATZ EXTRA STIFF GUIDE WIRE
K942382
Meadox Surgimed, Inc.
Cardiovascular · 95d
Cleared Aug 18, 1994
CARDIOMETRICS DUALFLOW SWITCH BOX
K940984
Cardio Metrics, Inc.
Cardiovascular · 170d
Cleared Jul 18, 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997
Boston Scientific Corp
Cardiovascular · 184d
Cleared May 31, 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES
K941485
Cardio Metrics, Inc.
Cardiovascular · 64d
Cleared May 24, 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895
Scimed Life Systems, Inc.
Cardiovascular · 36d
Cleared May 12, 1994
ONTRAC STEERABLE GUIDEWIRE
K941229
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared Mar 31, 1994
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS
K935170
Lake Region Mfg., Inc.
Cardiovascular · 155d
Cleared Mar 15, 1994
TORQUE DEVICE
K936032
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Mar 10, 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Feb 24, 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
K930982
Cordis Corp.
Cardiovascular · 364d
Cleared Feb 14, 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
K933334
Boston Scientific Corp
Cardiovascular · 202d
Cleared Jan 18, 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Dec 16, 1993
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE
K934602
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Dec 09, 1993
LOC GUIDE WIRE EXTENSION
K934339
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 93d
Cleared Oct 15, 1993
AUTOMATIC PULL BACK DEVICE
K933517
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
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 Aug 19, 1993
ARROW BLOOD CONTAINMENT DEVICE
K924558
Arrow Intl., Inc.
Cardiovascular · 344d
Cleared Aug 15, 1993
NEW HYDROPHILIC COATING FOR WIRE GUIDES
K924385
Arrow Intl., Inc.
Cardiovascular · 356d
Cleared Jul 14, 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
K931327
Peripheral Systems Group
Cardiovascular · 120d
Cleared Jul 09, 1993
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
K930787
Advanced Surgical, Inc.
Cardiovascular · 143d
Cleared Jun 25, 1993
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
K931514
Scimed Life Systems, Inc.
Cardiovascular · 91d