DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Medrad, Inc., Merit Medical Systems, Inc. and Bayer Medical Care, 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 Jul 29, 2016
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107
Merit Medical Systems, Inc.
Cardiovascular · 192d
Cleared Mar 25, 2016
DeRoyal Angiography Kits
K152978
Deroyal Industries, Inc.
Cardiovascular · 168d
Cleared Dec 15, 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133
Medrad, Inc.
Cardiovascular · 52d
Cleared Nov 28, 2011
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
K113198
Navilyst Medical, Inc.
Cardiovascular · 28d
Cleared Oct 14, 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
K112086
Medrad, Inc.
Cardiovascular · 85d
Cleared Mar 03, 2011
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830
Medline Industries, Inc.
Cardiovascular · 444d
Cleared Feb 04, 2009
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523
Merit Medical Systems, Inc.
Cardiovascular · 70d
Cleared Jan 12, 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
K082905
Medrad, Inc.
Cardiovascular · 104d
Cleared Dec 21, 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
K072886
Medrad, Inc.
Cardiovascular · 73d
Cleared Sep 27, 2006
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976
Toshiba America Medical Systems, In.C
Radiology · 76d
Cleared Jun 17, 2005
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
K050456
Medrad, Inc.
Cardiovascular · 114d
Cleared Dec 10, 2004
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
K042784
Medrad, Inc.
Cardiovascular · 65d
Cleared Mar 02, 2004
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
K033881
Medrad, Inc.
Cardiovascular · 78d
Cleared Nov 05, 2003
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K033247
Medrad, Inc.
Cardiovascular · 29d
Cleared Aug 01, 2003
MEDRAD MANUAL SYRINGE LOADER
K031483
Medrad, Inc.
Cardiovascular · 81d
Cleared Jan 10, 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183
Medrad, Inc.
Cardiovascular · 108d
Cleared Dec 13, 2001
MEDRAD QWIK-FIT SYRINGE
K013815
Medrad, Inc.
Cardiovascular · 27d
Cleared Oct 04, 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950
Medrad, Inc.
Cardiovascular · 30d