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
73–96 of 210
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 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
Cleared Aug 22, 2001
MONARCH INFLATION SYRINGE
K011811
Merit Medical Systems, Inc.
Cardiovascular · 72d
Cleared Aug 21, 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991
Medrad, Inc.
Cardiovascular · 56d
Cleared Mar 09, 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390
Acist Medical Systems, Inc.
Cardiovascular · 28d
Cleared Nov 16, 2000
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663
Medrad, Inc.
Cardiovascular · 169d
Cleared May 31, 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231
Invasatec
Cardiovascular · 553d
Cleared May 31, 2000
MODIFICATION TO ACIST CL 100H
K991103
Acist Medical Systems
Cardiovascular · 426d
Cleared Mar 23, 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826
Unimachs Corp.
Cardiovascular · 511d
Cleared Dec 07, 1999
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
K993774
Acist Medical Systems
Cardiovascular · 29d
Cleared Dec 06, 1999
OPTISTAR MR INJECTOR SYSTEM
K984088
Mallinckrodt Inc., Liebel-Flarsheim Business
Cardiovascular · 385d
Cleared Nov 26, 1999
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728
Medrad, Inc.
Cardiovascular · 22d
Cleared Jul 21, 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557
Medrad, Inc.
Cardiovascular · 78d
Cleared Mar 11, 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418
Medrad, Inc.
Cardiovascular · 91d
Cleared Oct 09, 1998
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814
Medrad, Inc.
Cardiovascular · 59d
Cleared Apr 03, 1998
OZ POWER SYRINGE
K973334
Cardiovascular Innovations
Cardiovascular · 211d
Cleared Dec 05, 1997
ACIST ANGIOGRAPHIC INJECTOR
K963982
Invasatec
Cardiovascular · 429d
Cleared Nov 25, 1997
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230
Merit Medical Systems, Inc.
Cardiovascular · 90d