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
121–144 of 501
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 Nov 18, 2004
METRICATH SYSTEM
K042685
Angiometrx, Inc.
Cardiovascular · 50d
Cleared Sep 23, 2004
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909
Vascular Solutions, Inc.
Cardiovascular · 70d
Cleared Aug 26, 2004
RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
K041123
Kerberos Proximal Solutions, Inc.
Cardiovascular · 118d
Cleared Jun 30, 2004
H-FLOW VALVE
K034043
Elcam Medical Acal
Cardiovascular · 184d
Cleared Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830
NuMED, Inc.
Cardiovascular · 79d
Cleared May 21, 2004
RINSPIRATION SYSTEM
K041291
Kerberos Proximal Solutions, Inc.
Cardiovascular · 7d
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
Cleared Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126
Abbott Laboratories
Cardiovascular · 29d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681
Boston Scientific Corp
Cardiovascular · 25d
Cleared Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621
Boston Scientific Corp
Cardiovascular · 28d
Cleared May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
K021283
Guidant Corp.
Cardiovascular · 14d
Cleared Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
K020890
St Jude Medical
Cardiovascular · 29d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
K020316
Cordis Corp.
Cardiovascular · 49d
Cleared Mar 13, 2002
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
K012983
Acist Medical Systems, Inc.
Cardiovascular · 189d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217
Abbott Laboratories
Cardiovascular · 26d
Cleared Mar 29, 2001
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
K010707
Boston Scientific, Target
Radiology · 20d