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
313–336 of 766
Cleared Oct 15, 2004
SILICONE COATED GUIDEWIRE
K041740
Arrow International, Inc.
Cardiovascular · 109d
Cleared Sep 16, 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338
Lake Region Mfg., Inc.
Cardiovascular · 17d
Cleared Aug 16, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K041973
Intra Luminal Therapeutics, Inc.
Cardiovascular · 25d
Cleared Aug 06, 2004
FINISHING WIRE SUPPORTRAK
K041762
Guidant Corporation
Cardiovascular · 37d
Cleared Aug 03, 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531
Asahi Intecc Co., Ltd.
Cardiovascular · 56d
Cleared Jul 16, 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared May 17, 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
K040825
Lake Region Mfg., Inc.
Cardiovascular · 48d
Cleared Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867
Boston Scientific Corp
Cardiovascular · 28d
Cleared Apr 19, 2004
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
K040786
Neometrics, Inc.
Cardiovascular · 21d
Cleared Mar 03, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K040037
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d
Cleared Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345
Ev3, Inc.
Cardiovascular · 19d
Cleared Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100
Arrow Intl., Inc.
Cardiovascular · 41d
Cleared Feb 12, 2004
IQ GUIDE WIRE
K040140
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jan 12, 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
K033742
Boston Scientific Corp
Cardiovascular · 45d
Cleared Jan 12, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033929
Intra Luminal Therapeutics, Inc.
Cardiovascular · 25d
Cleared Jan 07, 2004
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K032031
Intra Luminal Therapeutics, Inc.
Cardiovascular · 190d
Cleared Dec 19, 2003
HYDROPHILIC GUIDEWIRE
K033758
Lake Region Mfg., Inc.
Cardiovascular · 17d
Cleared Dec 11, 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033708
Intra Luminal Therapeutics, Inc.
Cardiovascular · 15d
Cleared Nov 05, 2003
SELECTIVA SB GUIDEWIRE
K033321
Neometrics, Inc.
Cardiovascular · 21d
Cleared Sep 30, 2003
VASCUPUNCTURE PICC GUIDEWIRE
K031652
Neometrics, Inc.
Cardiovascular · 125d
Cleared Sep 16, 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615
Asahi Intecc Co., Ltd.
Cardiovascular · 22d
Cleared Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K031678
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 13, 2003
PBN GUIDEWIRES
K031442
Medical Device Technologies, Inc.
Cardiovascular · 99d
Cleared Aug 08, 2003
PERIVAC KIT
K032050
Boston Scientific Corp
Cardiovascular · 37d