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
481–504 of 766
Cleared Sep 17, 1985
TELEFLEX GUIDEWIRE
K850677
Teleflexmedical, Inc.
Cardiovascular · 208d
Cleared Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Jun 26, 1985
GUIDE, WIRE, ANGIOGRAPHIC
K850827
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE - MODIFICATION
K850828
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 35d
Cleared Feb 08, 1985
BIOPATCH BOVINE PERICARDIAL PATCH
K840756
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 351d
Cleared Nov 29, 1984
WIREGUIDE OR GUIDEWIRE
K843012
Medi-Tech, Inc.
Cardiovascular · 121d
Cleared Feb 13, 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223
Mallinckrodt Critical Care
Cardiovascular · 69d
Cleared Dec 27, 1983
OPEN END SPRING GUIDE
K832607
C.R. Bard, Inc.
Cardiovascular · 146d
Cleared Jul 18, 1983
STAINLESS STEEL GUIDE WIRE
K831839
Quinton, Inc.
Cardiovascular · 41d
Cleared Aug 31, 1982
GUIDE WIRE
K821190
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 126d
Cleared Apr 09, 1982
CATHETER GUIDE WIRE
K820699
Quest Medical, Inc.
Cardiovascular · 25d
Cleared Mar 27, 1981
ARROW RADIAL ARTERY CATHETERIZATION SET
K810675
Arrow Intl., Inc.
Cardiovascular · 15d
Cleared Nov 12, 1980
BENZALKONIUM-HEPARIN COATED GUIDEWIRES
K802473
Medrad, Inc.
Cardiovascular · 3d
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
Cleared Oct 30, 1978
VARIABLE STIFFNESS WIRE GUIDE
K781393
Cook, Inc.
Cardiovascular · 81d
Cleared Jun 28, 1978
SAFETY SPRING GUIDES, TEFLON COATED
K780438
C.R. Bard, Inc.
Cardiovascular · 100d
Cleared Apr 10, 1978
ELECATH PLASTIC JACKETED GUIDEWIRE
K780493
Electro-Catheter Corp.
Cardiovascular · 14d
Cleared Jun 14, 1977
CARDIOVASCULAR SPRING GUIDES
K770977
Lake Region Mfg., Inc.
Cardiovascular · 14d
Cleared Dec 10, 1976
ANGIOGRAPHIC GUIDEWIRE
K760944
Medrad, Inc.
Cardiovascular · 39d