DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Medrad, Inc., Osprey Medical, Inc. and Coeur, Inc..

211
Total
211
Cleared
146d
Avg days
1978
Since
211 devices
73–96 of 211
Cleared May 02, 2008
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
K072696
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Cardiovascular · 221d
Cleared Dec 21, 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
K072886
Medrad, Inc.
Cardiovascular · 73d
Cleared Dec 19, 2007
DUAL SHOT ALPHA
K071691
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 182d
Cleared Oct 04, 2007
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
K070798
Coeur, Inc.
Cardiovascular · 195d
Cleared Sep 27, 2006
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976
Toshiba America Medical Systems, In.C
Radiology · 76d
Cleared Aug 18, 2006
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
K062168
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 18d
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
Cleared Nov 30, 2004
OPTIV ANTAGE DH POWER INJECTION SYSTEM
K042744
Mallinckrodt Inc., Liebel-Flarsheim Business
Cardiovascular · 57d
Cleared Mar 15, 2004
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
K040298
Acist Medical Systems, Inc.
Cardiovascular · 35d
Cleared Mar 02, 2004
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
K033881
Medrad, Inc.
Cardiovascular · 78d
Cleared Dec 16, 2003
THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
K032920
Coeur Medical
Cardiovascular · 85d
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 Jul 11, 2003
OPTIBOLUS
K031339
Mallinckrodt Inc., Liebel-Flarsheim Business
Cardiovascular · 74d
Cleared Jan 27, 2003
ACIST GENTOO CONTRAST INJECTION SYSTEM
K020892
Acist Medical Systems
Cardiovascular · 314d
Cleared Jan 10, 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183
Medrad, Inc.
Cardiovascular · 108d
Cleared Jul 26, 2002
ELPH INJECTION SYSTEM
K022116
Mallinckrodt Inc., Liebel-Flarsheim Business
Cardiovascular · 25d
Cleared Apr 25, 2002
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
K020333
Atrion Medical Products, Inc.
Cardiovascular · 84d
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