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
Cleared
Sep 17, 1985
TELEFLEX GUIDEWIRE
Teleflexmedical, Inc.
Cardiovascular
208d
Cleared
Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
Advanced Cardiovascular Systems, Inc.
Cardiovascular
56d
Cleared
Jun 26, 1985
GUIDE, WIRE, ANGIOGRAPHIC
Lake Region Mfg., Inc.
Cardiovascular
121d
Cleared
Jun 26, 1985
WIRE, GUIDE - MODIFICATION
Lake Region Mfg., Inc.
Cardiovascular
121d
Cleared
Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
Advanced Cardiovascular Systems, Inc.
Cardiovascular
63d
Cleared
Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
Advanced Cardiovascular Systems, Inc.
Cardiovascular
35d
Cleared
Feb 08, 1985
BIOPATCH BOVINE PERICARDIAL PATCH
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular
351d
Cleared
Nov 29, 1984
WIREGUIDE OR GUIDEWIRE
Medi-Tech, Inc.
Cardiovascular
121d
Cleared
Feb 13, 1984
CARDIOVASCULAR SPRING GUIDE WIRE
Mallinckrodt Critical Care
Cardiovascular
69d
Cleared
Dec 27, 1983
OPEN END SPRING GUIDE
C.R. Bard, Inc.
Cardiovascular
146d
Cleared
Jul 18, 1983
STAINLESS STEEL GUIDE WIRE
Quinton, Inc.
Cardiovascular
41d
Cleared
Aug 31, 1982
GUIDE WIRE
Advanced Cardiovascular Systems, Inc.
Cardiovascular
126d
Cleared
Apr 09, 1982
CATHETER GUIDE WIRE
Quest Medical, Inc.
Cardiovascular
25d
Cleared
Mar 27, 1981
ARROW RADIAL ARTERY CATHETERIZATION SET
Arrow Intl., Inc.
Cardiovascular
15d
Cleared
Nov 12, 1980
BENZALKONIUM-HEPARIN COATED GUIDEWIRES
Medrad, Inc.
Cardiovascular
3d
Cleared
Jul 24, 1979
PERVENOUS LEAD INTRODUCER SYSTEM
Cordis Corp.
Cardiovascular
15d
Cleared
Feb 23, 1979
MOVABLE CORE SAFETY GUIDE
Cordis Corp.
Cardiovascular
17d
Cleared
Oct 30, 1978
VARIABLE STIFFNESS WIRE GUIDE
Cook, Inc.
Cardiovascular
81d
Cleared
Jun 28, 1978
SAFETY SPRING GUIDES, TEFLON COATED
C.R. Bard, Inc.
Cardiovascular
100d
Cleared
Apr 10, 1978
ELECATH PLASTIC JACKETED GUIDEWIRE
Electro-Catheter Corp.
Cardiovascular
14d
Cleared
Jun 14, 1977
CARDIOVASCULAR SPRING GUIDES
Lake Region Mfg., Inc.
Cardiovascular
14d
Cleared
Dec 10, 1976
ANGIOGRAPHIC GUIDEWIRE
Medrad, Inc.
Cardiovascular
39d