DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Medrad, Inc., Osprey Medical, Inc. and Acist Medical Systems, Inc..

210
Total
210
Cleared
146d
Avg days
1978
Since
210 devices
49–72 of 210
Cleared Aug 14, 2015
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
K143538
Bayer Medical Care, Inc.
Cardiovascular · 242d
Cleared Apr 01, 2015
125mL CT Syringe
K142745
Coeur, Inc.
Cardiovascular · 189d
Cleared Mar 26, 2015
AVERT Contrast Modulation System
K150485
Osprey Medical, Inc.
Cardiovascular · 30d
Cleared Dec 12, 2014
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
K142081
Osprey Medical, Inc.
Cardiovascular · 134d
Cleared Jul 28, 2014
MR SYRINGE DUAL PACK
K140469
Coeur, Inc.
Cardiovascular · 153d
Cleared Jun 30, 2014
DUAL SHOT ALPHA 7
K133189
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 256d
Cleared Jun 11, 2014
CONTRAST MODULATION SYSTEM
K140425
Osprey Medical, Inc.
Cardiovascular · 112d
Cleared Apr 30, 2014
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
K133600
Coeur, Inc.
Cardiovascular · 156d
Cleared Jan 23, 2014
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
K132928
Medrad, Inc. / Bayer Medical Care, Inc.
Cardiovascular · 127d
Cleared Aug 15, 2013
CONTRAST CONSERVATION SYSTEM
K131478
Osprey Medical, Inc.
Cardiovascular · 85d
Cleared Jun 10, 2013
DISPOSABLE 330PSI EXTENSION LINES
K120892
Coeur, Inc.
Cardiovascular · 444d
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 Dec 16, 2005
C2000 AUTOMATED MANIFOLD KIT
K052744
Acist Medical Systems, Inc.
Cardiovascular · 77d
Cleared Nov 02, 2005
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
K051799
Coeur, Inc.
Cardiovascular · 120d
Cleared Oct 17, 2005
DUAL SHOT - CONTRAST DELIVERY SYSTEM
K052633
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 21d
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