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
73–96 of 501
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 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 02, 2006
LANGSTON DUAL LUMEN CATHETER
K061565
Vascular Solutions, Inc.
Cardiovascular · 58d
Cleared Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175
Boston Scientific Corp
Cardiovascular · 60d
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
Cleared May 20, 2005
ATLANTIS PV
K050684
Boston Scientific Corp
Radiology · 64d
Cleared May 18, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K050168
Vascular Solutions, Inc.
Cardiovascular · 112d
Cleared Mar 30, 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577
Boston Scientific Corp
Cardiovascular · 23d
Cleared Sep 23, 2004
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909
Vascular Solutions, Inc.
Cardiovascular · 70d
Cleared Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830
NuMED, Inc.
Cardiovascular · 79d
Cleared Apr 29, 2004
ATLANTIS SR, MODEL C4020
K040776
Boston Scientific Corp
Cardiovascular · 34d
Cleared Dec 12, 2003
PROGREAT
K033583
Terumo Medical Corp.
Cardiovascular · 29d
Cleared Aug 26, 2003
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
K032376
AngioDynamics, Inc.
Cardiovascular · 25d
Cleared Jun 18, 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591
Deroyal Industries, Inc.
Cardiovascular · 236d