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
Cleared
Jul 16, 2019
Impress Angiographic Catheter
Merit Medical Systems, Inc.
Cardiovascular
29d
Cleared
Mar 22, 2019
Polyethylene Catheter
Cook Incorporated
Cardiovascular
266d
Cleared
Dec 19, 2018
Arterial Pressure Monitoring Set/Tray
Cook Incorporated
Cardiovascular
261d
Cleared
Nov 30, 2018
Arterial Pressure Monitoring Set/Tray
Cook Incorporated
Cardiovascular
248d
Cleared
Oct 26, 2018
Polyethylene Catheter
Cook Incorporated
Cardiovascular
267d
Cleared
Oct 05, 2018
Royal Flush Plus High-Flow Catheter
Cook Incorporated
Cardiovascular
270d
Cleared
Aug 08, 2018
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
Cordis, A Cardinal Health Company
Cardiovascular
29d
Cleared
Jul 18, 2018
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
AngioDynamics, Inc.
Cardiovascular
219d
Cleared
Apr 03, 2018
High-Flo Silver Polyethylene Catheter
Cook Incorporated
Cardiovascular
214d
Cleared
Apr 03, 2018
Surefire Spark Infusion System
Surefire Medical, Inc.
Cardiovascular
19d
Cleared
Jan 26, 2018
SeQure® NF and SeQure® Microcatheters
Accurate Medical Therapeutics, Ltd.
Cardiovascular
85d
Cleared
Jan 25, 2018
Royal Flush Catheter
Cook Incorporated
Cardiovascular
269d
Cleared
Nov 17, 2017
Langston dual lumen catheter
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
Cook Incorporated
Cardiovascular
30d
Cleared
May 26, 2017
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
Cook Incorporated
Cardiovascular
267d
Cleared
Apr 28, 2017
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
AngioDynamics, Inc.
Cardiovascular
323d
Cleared
Jan 19, 2017
Medline Waste Station
Medline Industries, Inc.
Cardiovascular
317d
Cleared
Jan 06, 2017
NAMIC ClearaCIL Contrast Injection Lines
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
Medtronic Vascular
Cardiovascular
102d
Cleared
Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
Boston Scientific Corporation
Cardiovascular
48d
Cleared
Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
99d
Cleared
Aug 17, 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
Medline Industries, Inc.
Cardiovascular
227d
Cleared
May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
94d
Cleared
Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
Boston Scientific Corp
Cardiovascular
6d