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
49–72 of 211
Cleared Sep 21, 2015
AVERT Contrast Modulation System
K152218
Osprey Medical
Cardiovascular · 45d
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 Oct 29, 2010
REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
K092896
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 403d
Cleared Oct 19, 2009
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
K090487
Coeur, Inc.
Cardiovascular · 236d
Cleared Jun 19, 2009
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
K090621
Flowcardia, Inc.
Cardiovascular · 102d
Cleared Mar 23, 2009
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
K082439
Shandong Weigao Medical Polymer Co., Ltd.
Cardiovascular · 210d
Cleared Feb 04, 2009
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523
Merit Medical Systems, Inc.
Cardiovascular · 70d
Cleared Jan 22, 2009
SYRINGE WITH HANDI-FIL
K082212
Mallinckrodt Inc., Liebel-Flarsheim Business
Cardiovascular · 169d
Cleared Jan 12, 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
K082905
Medrad, Inc.
Cardiovascular · 104d
Cleared May 07, 2008
OPTISTAR ELITE INJECTION SYSTEM
K073592
Mallinckrodt Inc., Liebel-Flarsheim Business
Cardiovascular · 139d