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
313–336 of 501
Cleared Apr 24, 1989
USCI 7F GUIDE CATHETER
K890420
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Apr 21, 1989
IMAGER FLUSH CATHETERS
K884354
Medi-Tech, Inc.
Cardiovascular · 186d
Cleared Jan 18, 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502
C.R. Bard, Inc.
Cardiovascular · 84d
Cleared Jan 12, 1989
CATH LAB MONITORING CATHETER
K884065
C.R. Bard, Inc.
Cardiovascular · 108d
Cleared Nov 18, 1988
MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER
K883651
Millar Instruments, Inc.
Cardiovascular · 84d
Cleared Oct 06, 1988
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Jul 28, 1988
SLIP-COAT(TM) CATHETERS
K882796
Cook, Inc.
Cardiovascular · 22d
Cleared Feb 05, 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815
Target Therapeutics
Cardiovascular · 77d
Cleared Nov 27, 1987
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Sep 15, 1987
GUIDING CATHETER
K873004
Mallinckrodt Critical Care
Cardiovascular · 42d
Cleared Aug 12, 1987
DOUBLE LUMEN CATHETER
K872248
Cordis Corp.
Cardiovascular · 61d
Cleared Feb 20, 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943
NuMED, Inc.
Cardiovascular · 65d
Cleared Feb 19, 1987
NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940
NuMED, Inc.
Cardiovascular · 64d
Cleared Nov 03, 1986
CORDIS CONTRAST INJECTION LINES
K864141
Cordis Corp.
Cardiovascular · 12d
Cleared Oct 10, 1986
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER
K863137
Terumo Medical Corp.
Cardiovascular · 56d
Cleared Sep 11, 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673
Medtronic Vascular
Cardiovascular · 59d
Cleared Aug 29, 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466
Shiley, Inc.
Cardiovascular · 60d
Cleared Aug 28, 1986
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
K862464
Shiley, Inc.
Cardiovascular · 59d
Cleared Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244
Cordis Corp.
Cardiovascular · 74d
Cleared Aug 11, 1986
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465
Shiley, Inc.
Cardiovascular · 42d
Cleared Jul 17, 1986
ANGIOFLOW
K854910
Angiomed U.S., Inc.
Cardiovascular · 220d
Cleared Jul 10, 1986
ACS CORONARY GUIDING CATHETER
K861236
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 99d
Cleared Jul 02, 1986
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
K860867
Medical Components, Inc.
Cardiovascular · 117d
Cleared Jun 27, 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006
Cordis Corp.
Cardiovascular · 31d