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
169–192 of 501
Cleared Nov 03, 1993
DYE MANAGEMENT SYSTEM
K933700
Abbott Laboratories
Cardiovascular · 97d
Cleared Oct 06, 1993
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K931479
Mallinckrodt Medical
Cardiovascular · 196d
Cleared Aug 17, 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Aug 16, 1993
ANGIOGRAPHIC CATHETER
K926243
Target Therapeutics
Cardiovascular · 248d
Cleared Aug 11, 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Jul 29, 1993
USCI ANGIOGRAPHIC CATHETER
K932092
C.R. Bard, Inc.
Cardiovascular · 90d
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 Apr 21, 1993
NYLEX CATHETERS
K930479
Cordis Corp.
Cardiovascular · 82d
Cleared Mar 11, 1993
RETRIEVER 10
K921649
Target Therapeutics
Cardiovascular · 339d
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 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 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
Cleared Dec 18, 1991
ANGIOGRAPHIC SOFT TIP CATHETER
K914199
E-Z-Em, Inc.
Cardiovascular · 90d