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..

500
Total
500
Cleared
122d
Avg days
1976
Since
500 devices
25–48 of 500
Cleared Jul 16, 2019
Impress Angiographic Catheter
K191608
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2019
Polyethylene Catheter
K181722
Cook Incorporated
Cardiovascular · 266d
Cleared Dec 19, 2018
Arterial Pressure Monitoring Set/Tray
K180846
Cook Incorporated
Cardiovascular · 261d
Cleared Nov 30, 2018
Arterial Pressure Monitoring Set/Tray
K180792
Cook Incorporated
Cardiovascular · 248d
Cleared Oct 26, 2018
Polyethylene Catheter
K180286
Cook Incorporated
Cardiovascular · 267d
Cleared Oct 05, 2018
Royal Flush Plus High-Flow Catheter
K180054
Cook Incorporated
Cardiovascular · 270d
Cleared Aug 08, 2018
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
K181836
Cordis, A Cardinal Health Company
Cardiovascular · 29d
Cleared Jul 18, 2018
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
K173762
AngioDynamics, Inc.
Cardiovascular · 219d
Cleared Apr 03, 2018
High-Flo Silver Polyethylene Catheter
K172635
Cook Incorporated
Cardiovascular · 214d
Cleared Apr 03, 2018
Surefire Spark Infusion System
K180677
Surefire Medical, Inc.
Cardiovascular · 19d
Cleared Jan 26, 2018
SeQure® NF and SeQure® Microcatheters
K173430
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 85d
Cleared Jan 25, 2018
Royal Flush Catheter
K171264
Cook Incorporated
Cardiovascular · 269d
Cleared Nov 17, 2017
Langston dual lumen catheter
K170544
Vascular Solutions, Inc.
Cardiovascular · 266d
Cleared Nov 15, 2017
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
K173289
Cook Incorporated
Cardiovascular · 30d
Cleared May 26, 2017
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
K162448
Cook Incorporated
Cardiovascular · 267d
Cleared Apr 28, 2017
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
K161596
AngioDynamics, Inc.
Cardiovascular · 323d
Cleared Jan 19, 2017
Medline Waste Station
K160660
Medline Industries, Inc.
Cardiovascular · 317d
Cleared Jan 06, 2017
NAMIC ClearaCIL Contrast Injection Lines
K163141
AngioDynamics, Inc.
Cardiovascular · 58d
Cleared Aug 19, 2016
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
K161287
Medtronic Vascular
Cardiovascular · 102d
Cleared Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
K152605
Boston Scientific Corporation
Cardiovascular · 48d
Cleared Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
K121694
Boston Scientific Corp
Cardiovascular · 99d
Cleared Aug 17, 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
K120008
Medline Industries, Inc.
Cardiovascular · 227d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495
Boston Scientific Corp
Cardiovascular · 94d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893
Boston Scientific Corp
Cardiovascular · 6d