DQO · Class II · 21 CFR 870.1200

FDA Product Code DQO: Catheter, Intravascular, Diagnostic

FDA product code DQO covers diagnostic intravascular catheters used for hemodynamic assessment and angiography.

These catheters are advanced into heart chambers or vessels to measure intracardiac and intravascular pressures, sample blood for oxygen saturation, and inject contrast for angiographic imaging. They are used in cardiac catheterization laboratory diagnostic studies.

DQO devices are Class II medical devices, regulated under 21 CFR 870.1200 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Cordis Corp., Boston Scientific Corp and C.R. Bard, Inc..

501
Total
501
Cleared
122d
Avg days
1976
Since
501 devices
97–120 of 501
Cleared Jan 28, 2009
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
K081846
Vascular Solutions, Inc.
Cardiovascular · 212d
Cleared Sep 24, 2008
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736
Terumo Medical Corp.
Cardiovascular · 6d
Cleared Apr 17, 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
K073585
Vascular Solutions, Inc.
Cardiovascular · 119d
Cleared Feb 01, 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
K073200
Vascular Solutions, Inc.
Cardiovascular · 80d
Cleared Dec 18, 2007
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
K072796
Concentric Medical, Inc.
Cardiovascular · 78d
Cleared Oct 05, 2007
MICRUS COURIER ENZO MICROCATHETER 0.0190
K072526
Micrus Endovascular Corporation
Cardiovascular · 28d
Cleared May 24, 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
K070456
Micrus Endovascular Corporation
Cardiovascular · 97d
Cleared Apr 16, 2007
DYE MANAGEMENT SYSTEM
K063784
Icu Medical, Inc.
Cardiovascular · 116d
Cleared Jan 18, 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
K062877
Vascular Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 05, 2007
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
K062627
Vascular Solutions, Inc.
Cardiovascular · 122d
Cleared Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
K063312
Boston Scientific Corp
Radiology · 28d
Cleared Aug 24, 2006
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K061733
AngioDynamics, Inc.
Cardiovascular · 65d
Cleared Aug 04, 2006
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
K061963
Micrus Endovascular Corporation
Cardiovascular · 23d
Cleared Aug 02, 2006
LANGSTON DUAL LUMEN CATHETER
K061565
Vascular Solutions, Inc.
Cardiovascular · 58d
Cleared Jun 23, 2006
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
K052908
Infraredx, Inc.
Cardiovascular · 252d
Cleared May 12, 2006
MICRUS COURIER MICROCATHETERS
K060116
Micrus Endovascular Corporation
Cardiovascular · 115d
Cleared Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175
Boston Scientific Corp
Cardiovascular · 60d
Cleared Mar 08, 2006
THEROX INFUSION CATHETER, MODEL INCA-1
K052637
Therox, Inc.
Cardiovascular · 163d
Cleared Jan 19, 2006
MERIT IMPRESS DIAGNOSTIC CATHETER
K053171
Merit Medical Systems, Inc.
Cardiovascular · 66d
Cleared Dec 22, 2005
HOSPIRA CATH LAB CONVENIENCE KITS
K052865
Icu Medical, Inc.
Cardiovascular · 72d
Cleared Nov 02, 2005
ASAHI ANGIOGRAPHIC CATHETER
K051561
Asahi Intecc Co., Ltd.
Cardiovascular · 142d
Cleared Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
K050863
Boston Scientific Corp
Cardiovascular · 150d
Cleared Jun 24, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K051395
Vascular Solutions, Inc.
Cardiovascular · 28d
Cleared Jun 07, 2005
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
K050371
Medrad, Inc.
Cardiovascular · 113d