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
Oct 15, 2004
SILICONE COATED GUIDEWIRE
Arrow International, Inc.
Cardiovascular
109d
Cleared
Sep 16, 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
17d
Cleared
Aug 16, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Intra Luminal Therapeutics, Inc.
Cardiovascular
25d
Cleared
Aug 06, 2004
FINISHING WIRE SUPPORTRAK
Guidant Corporation
Cardiovascular
37d
Cleared
Aug 03, 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
Asahi Intecc Co., Ltd.
Cardiovascular
56d
Cleared
Jul 16, 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
30d
Cleared
May 17, 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
48d
Cleared
Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
Boston Scientific Corp
Cardiovascular
28d
Cleared
Apr 19, 2004
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
Neometrics, Inc.
Cardiovascular
21d
Cleared
Mar 03, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Intra Luminal Therapeutics, Inc.
Cardiovascular
54d
Cleared
Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
Ev3, Inc.
Cardiovascular
19d
Cleared
Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
Arrow Intl., Inc.
Cardiovascular
41d
Cleared
Feb 12, 2004
IQ GUIDE WIRE
Boston Scientific Corp
Cardiovascular
21d
Cleared
Jan 12, 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
Boston Scientific Corp
Cardiovascular
45d
Cleared
Jan 12, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Intra Luminal Therapeutics, Inc.
Cardiovascular
25d
Cleared
Jan 07, 2004
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Intra Luminal Therapeutics, Inc.
Cardiovascular
190d
Cleared
Dec 19, 2003
HYDROPHILIC GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
17d
Cleared
Dec 11, 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Intra Luminal Therapeutics, Inc.
Cardiovascular
15d
Cleared
Nov 05, 2003
SELECTIVA SB GUIDEWIRE
Neometrics, Inc.
Cardiovascular
21d
Cleared
Sep 30, 2003
VASCUPUNCTURE PICC GUIDEWIRE
Neometrics, Inc.
Cardiovascular
125d
Cleared
Sep 16, 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
Asahi Intecc Co., Ltd.
Cardiovascular
22d
Cleared
Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
Guidant Corp.
Cardiovascular
88d
Cleared
Aug 13, 2003
PBN GUIDEWIRES
Medical Device Technologies, Inc.
Cardiovascular
99d
Cleared
Aug 08, 2003
PERIVAC KIT
Boston Scientific Corp
Cardiovascular
37d