DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Bayer Medical Care, Inc., Acist Medical Systems, Inc. and C.R. Bard, Inc..

210
Total
210
Cleared
146d
Avg days
1978
Since
210 devices
25–48 of 210
Cleared Oct 10, 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289
Shenzhen Baoan Medical Supplies Co., Ltd.
Cardiovascular · 48d
Cleared Aug 17, 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
K173773
Bayer Medical Care, Inc.
Cardiovascular · 248d
Cleared Jul 06, 2018
Sterile Disposable Syringes
K172694
Shenyang Mastech Medical Device Co., Ltd.
Cardiovascular · 302d
Cleared Feb 16, 2018
ACISTCVi® Contrast Delivery System
K171646
Acist Medical Systems, Inc.
Cardiovascular · 256d
Cleared Feb 07, 2018
PRESS DUO elite, PRESS DUO elite AG
K173450
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 93d
Cleared Jun 15, 2017
Merit Coronary Control Syringe
K163084
Merit Medical Systems, Inc.
Cardiovascular · 224d
Cleared Mar 03, 2011
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830
Medline Industries, Inc.
Cardiovascular · 444d
Cleared May 29, 1991
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 89d
Cleared Jan 19, 1990
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 143d
Cleared Jan 19, 1990
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared Oct 31, 1986
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
K863537
Cordis Corp.
Cardiovascular · 50d
Cleared Sep 23, 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037
C.R. Bard, Inc.
Cardiovascular · 42d
Cleared Jan 13, 1984
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107
Cordis Corp.
Cardiovascular · 45d
Cleared Dec 11, 1979
USCI BALLOON DILATATION INFLATION DEV.
K791782
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Dec 11, 1979
USCI PRESSURE GAUGE
K791793
C.R. Bard, Inc.
Cardiovascular · 88d