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
241–264 of 501
Cleared Jun 29, 1993
BALT GUIDING CATHETER
K925632
Target Therapeutics
Cardiovascular · 232d
Cleared Jun 23, 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891
Cordis Corp.
Cardiovascular · 372d
Cleared Jun 07, 1993
SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
K926003
Schneider Intl., Ltd.
Cardiovascular · 192d
Cleared Jun 02, 1993
CVIS LONGVIEW
K930311
Cardiovascular Imaging Systems, Inc.
Radiology · 132d
Cleared Apr 21, 1993
NYLEX CATHETERS
K930479
Cordis Corp.
Cardiovascular · 82d
Cleared Mar 11, 1993
RETRIEVER 10
K921649
Target Therapeutics
Cardiovascular · 339d
Cleared Mar 03, 1993
MORSE(R) ANGIOGRAPHIC CATHETERS
K922552
North American Instrument Corp.
Cardiovascular · 278d
Cleared Feb 12, 1993
ANGIOGRAPHIC CATHETER -- MODIFICATION
K922101
Interventional Therapeutics Corp.
Cardiovascular · 282d
Cleared Dec 03, 1992
COBE SAMPLING SITE
K922484
Cobe Cardiovascular, Inc.
Cardiovascular · 190d
Cleared Nov 17, 1992
USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING
K922105
C.R. Bard, Inc.
Cardiovascular · 195d
Cleared Nov 10, 1992
INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT
K921845
Becton Dickinson Vascular Access, Inc.
Cardiovascular · 207d
Cleared Oct 06, 1992
SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA
K923480
Scimed Life Systems, Inc.
Cardiovascular · 83d
Cleared Sep 21, 1992
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
K915726
Baxter Healthcare Corp
Cardiovascular · 276d
Cleared Sep 17, 1992
CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER
K921310
Cordis Corp.
Cardiovascular · 182d
Cleared Sep 01, 1992
LUKENS 2-0 BRAIDED SILK SUTURES
K922254
Quinton, Inc.
Cardiovascular · 203d
Cleared Aug 24, 1992
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT
K920980
C.R. Bard, Inc.
Cardiovascular · 175d
Cleared Jul 16, 1992
CBIS CATHETER PULL-BACK DEVICE
K921879
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jun 29, 1992
SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER
K915351
Medtronics Interventional Vascular
Cardiovascular · 216d
Cleared Jun 03, 1992
CARDIAC CATHERIZATION KIT
K914299
Abbott Laboratories
Cardiovascular · 252d
Cleared Apr 17, 1992
CORDIS ANGIOGRAPHIC DOPPLER CATHER
K915498
Cordis Corp.
Cardiovascular · 130d
Cleared Apr 07, 1992
DESERET GUIDEWIRE INTRODUCER II
K920407
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 67d
Cleared Apr 07, 1992
DESERET GUIDEWIRE INTRODUCER III
K920408
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 67d
Cleared Feb 11, 1992
CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS
K915836
Cordis Corp.
Cardiovascular · 49d
Cleared Feb 04, 1992
TERUMO ANGIOGTAPHIC CATHETER
K915414
Terumo Medical Corp.
Cardiovascular · 64d