FDA 510(k) Applications for Medical Device Product Code "DXT"
(Injector And Syringe, Angiographic)

FDA 510(k) Number Applicant Device Name Decision Date
K900034 ACCUMED SYSTEMS, INC. ANGIO-MAX 05/22/1990
K993774 ACIST MEDICAL SYSTEMS ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH 12/07/1999
K000013 ACIST MEDICAL SYSTEMS ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 03/28/2000
K020892 ACIST MEDICAL SYSTEMS ACIST GENTOO CONTRAST INJECTION SYSTEM 01/27/2003
K991103 ACIST MEDICAL SYSTEMS MODIFICATION TO ACIST CL 100H 05/31/2000
K010390 ACIST MEDICAL SYSTEMS, INC. ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS 03/09/2001
K040298 ACIST MEDICAL SYSTEMS, INC. ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS 03/15/2004
K171646 ACIST Medical Systems, Inc. ACISTCVi« Contrast Delivery System 02/16/2018
K052744 ACIST MEDICAL SYSTEMS, INC. C2000 AUTOMATED MANIFOLD KIT 12/16/2005
K854310 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ACS INDEFLATOR (MODIFICATION) 12/04/1985
K883452 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ACS INDEFLATOR P/T 20 10/14/1988
K872981 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ACS INDEFLATOR PLUS (MODIFICATION #2) 10/20/1987
K844045 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT 11/13/1984
K863596 AMERICAN EDWARDS LABORATORIES CHIN-FOGARTY INFLATION DEVICE 11/20/1986
K862547 AMERICAN EDWARDS LABORATORIES MECHANICAL INFLATION DEVICE 09/03/1986
K902377 ANGEION CORP. ANGEFLATOR(TM) 12/13/1990
K933846 ANGIODYNAMICS, DIV. E-Z-EM, INC. ANGIOGRAPHY SYRINGE KITS 12/13/1994
K872472 ANGIOMEDICS, INC. SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE 09/14/1987
K942381 APOGEE, INC. LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING 03/17/1995
K880987 APPLIED VASCULAR DEVICES, INC. INJECTOR HANDLE WITH SYRINGE 05/13/1988
K904994 ARGON MEDICAL CORP. CLOSED SYSTEM FLUSH SET 01/15/1991
K880310 ARROW INTL., INC. ANGIO DRAPE PACK ACP-010FM 04/22/1988
K790835 ATOMIC PRODUCTS CORP. DYNAJECT 06/22/1979
K020333 ATRION MEDICAL PRODUCTS, INC. ATRION MEDICAL QL FLUID DISPENSING SYRINGE 04/25/2002
K955381 B. BRAUN MEDICAL, INC. B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT 02/21/1996
K960674 B. BRAUN MEDICAL, INC. CONTRAST INJECTION LINES 09/19/1996
K962141 B. BRAUN MEDICAL, INC. VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 03/19/1997
K173773 Bayer Medical Care Inc. 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 08/17/2018
K143538 BAYER MEDICAL CARE INC. MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit 08/14/2015
K895318 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ANGIOGRAPHIC CONTROL SYRINGE 01/19/1990
K910873 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP 05/29/1991
K873410 BLOOD GAS SUPPLY CO. DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE 03/25/1988
K863037 C.R. BARD, INC. USCI (R) DISPOSABLE INFLATION DEVICE 09/23/1986
K791782 C.R. BARD, INC. USCI BALLOON DILATATION INFLATION DEV. 12/11/1979
K791793 C.R. BARD, INC. USCI PRESSURE GAUGE 12/11/1979
K896415 C.R. BARD, INC. USCI PRESTO DISPOSABLE INFLATION DEVICE 01/19/1990
K902475 CARDIO-PAK CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS 12/03/1990
K973334 CARDIOVASCULAR INNOVATIONS OZ POWER SYRINGE 04/03/1998
K971712 COEUR LABORATORIES, INC. COEUR 130 ML ANGIOGRAPHIC SYRINGE 10/08/1997
K823920 COEUR LABORATORIES, INC. COEURLOCK STERILE DISPOS. ANGIOGRAPHIC 02/18/1983
K960965 COEUR LABORATORIES, INC. FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 09/12/1996
K890292 COEUR LABORATORIES, INC. PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE 06/22/1989
K873597 COEUR LABORATORIES, INC. TUBING, POLYETHYLENE 11/12/1987
K032920 COEUR MEDICAL THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 12/16/2003
K142745 COEUR, INC. 125mL CT Syringe 04/01/2015
K150902 COEUR, INC. 330psi Extension Y-Line with Dual Check Valve 10/22/2015
K070798 COEUR, INC. ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS 10/04/2007
K133600 COEUR, INC. COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR 04/30/2014
K170431 Coeur, Inc. CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip 08/18/2017
K120892 COEUR, INC. DISPOSABLE 330PSI EXTENSION LINES 06/10/2013
K090487 COEUR, INC. DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 10/19/2009
K051799 COEUR, INC. DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS 11/02/2005
K140469 COEUR, INC. MR SYRINGE DUAL PACK 07/28/2014
K161471 Coeur, Inc. MR Syringe Dual Pack for Solaris Injectors 10/06/2016
K955684 CONTOUR FABRICATORS OF FLORIDA, INC. RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY 05/02/1996
K955685 CONTOUR FABRICATORS OF FLORIDA, INC. RNS STERILE, DISPOSABLE CT BIOPSY TRAY 10/04/1996
K834107 CORDIS CORP. ANGIOPLASTY INFLATION DEVICE & CARTR 01/13/1984
K863537 CORDIS CORP. CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY 10/31/1986
K152978 DEROYAL INDUSTRIES, INC. DeRoyal Angiography Kits 03/25/2016
K910594 DOW CORNING WRIGHT TRAC-WRIGHT SYSTEM, MODEL TW2 09/23/1991
K890208 E-Z-EM, INC. HIGH PRESSURE CONNECTING SETS 05/19/1989
K841493 E.A. FISCHIONE INSTRUMENT MFG. MODEL 1000 APC-ANGIOPLASTY PRESSURE 06/11/1984
K162088 ECOMED SOLUTIONS, LLC Ecomed Disposable Angiographic Syringes 01/27/2017
K881521 ENGINEERING, INC. MODIFIED SERVO SYRINGE 05/31/1988
K090621 FLOWCARDIA, INC. FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 06/19/2009
K821401 FORMA SCIENTIFIC, INC. MALLINCKRODT DIAG. MEDIA WARMER 06/17/1982
K823356 FORMA SCIENTIFIC, INC. READY-BOX BODY-TEMP MEDIA WARMER MALLIN- 12/03/1982
K833645 GISH BIOMEDICAL, INC. CONTRAST MEDIA INJECT. SET CMS 04/17/1984
K901382 HEALTHDYNE CARDIOVASCULAR, INC. ISOFLO(TM) HIGH PRESSURE INJECTION LINES 07/19/1990
K830609 INTERVENTIONAL MEDICAL, INC. INFLATION DEVICE 03/24/1983
K963982 INVASATEC ACIST ANGIOGRAPHIC INJECTOR 12/05/1997
K984231 INVASATEC ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B 05/31/2000
K944875 LIEVEL-FLARSHEIM CO. ANGIOMAT 3000, 6000, CT INJECTOR 01/04/1995
K860204 MALLINCKRODT GROUP, INC. ANGIOMAT 6000 05/02/1986
K873687 MALLINCKRODT GROUP, INC. ANGIOMAT CT INJECTOR 10/09/1987
K912944 MALLINCKRODT GROUP, INC. CT 8000 DIGITAL INJECTION SYSTEM 02/04/1992
K781334 MALLINCKRODT GROUP, INC. DISPOSABLE SYRINGE FILL TUBE 08/17/1978
K882329 MALLINCKRODT GROUP, INC. L-F COILED EXTENSION TUBING 09/02/1988
K902221 MALLINCKRODT GROUP, INC. MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE 08/08/1990
K963071 MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ANGIOMAT ILLUMENA 09/23/1997
K022116 MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ELPH INJECTION SYSTEM 07/26/2002
K031339 MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS OPTIBOLUS 07/11/2003
K073592 MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS OPTISTAR ELITE INJECTION SYSTEM 05/07/2008
K984088 MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS OPTISTAR MR INJECTOR SYSTEM 12/06/1999
K042744 MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS OPTIV ANTAGE DH POWER INJECTION SYSTEM 11/30/2004
K082212 MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS SYRINGE WITH HANDI-FIL 01/22/2009
K904212 MALLINCKRODT MEDICAL HIGH-PRESSURE CONNECTOR TUBE 12/03/1990
K880877 MED-WEST, INC. CONTRAST INJECTION DEVICE 05/31/1988
K851402 MEDI-TECH, INC. LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE 06/10/1985
K850861 MEDICAL COMPONENTS, INC. ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE 02/18/1986
K830754 MEDICAL PARAMETERS, INC. BLOOD PRESSURE MONITORING KITS,WALRUS 08/12/1983
K883769 MEDICAL PROFILES, INC. EXCEL INFLATE-AID 12/01/1988
K093830 MEDLINE INDUSTRIES, INC. MEDLINE ANGIOGRAPHIC CONTROL SYRINGE 03/03/2011
K840281 MEDRAD, INC. ANGIOGRAPHIC DRAPE PACKS 04/17/1984
K800613 MEDRAD, INC. ANGIOPLASTY INJECTOR 04/08/1980
K001663 MEDRAD, INC. FRONT-LOAD POLYPROPYLENE SYRINGE 11/16/2000
K822536 MEDRAD, INC. MARK V 09/28/1982
K050456 MEDRAD, INC. MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM 06/17/2005
K933908 MEDRAD, INC. MEDRAD CT CUSTOM CONVENIENCE KIT 02/25/1994
K964642 MEDRAD, INC. MEDRAD DISPOSABLE SYRINGES 04/29/1997
K934086 MEDRAD, INC. MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE 06/15/1995
K993728 MEDRAD, INC. MEDRAD ENVISION CT INJECTOR SYSTEM 11/26/1999
K031483 MEDRAD, INC. MEDRAD MANUAL SYRINGE LOADER 08/01/2003
K112086 MEDRAD, INC. MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE 10/14/2011
K113133 MEDRAD, INC. MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE 12/15/2011
K903390 MEDRAD, INC. MEDRAD MARK V-PLUS INJECTOR 09/26/1990
K924116 MEDRAD, INC. MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD 01/21/1993
K913624 MEDRAD, INC. MEDRAD MCT-PLUS INJECTOR 07/30/1992
K880493 MEDRAD, INC. MEDRAD MICROPROCESSOR CT INJECTION SYSTEM 04/28/1988
K873173 MEDRAD, INC. MEDRAD MRI INJECTION SYSTEM 02/05/1988
K013815 MEDRAD, INC. MEDRAD QWIK-FIT SYRINGE 12/13/2001
K935668 MEDRAD, INC. MEDRAD SPECTRIS MR INJECTOR 09/25/1995
K042784 MEDRAD, INC. MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM 12/10/2004
K033247 MEDRAD, INC. MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM 11/05/2003
K023183 MEDRAD, INC. MEDRAD STELLANT CT INJECTOR SYSTEM 01/10/2003
K033881 MEDRAD, INC. MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE 03/02/2004
K072886 MEDRAD, INC. MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T 12/21/2007
K082905 MEDRAD, INC. MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC 01/12/2009
K905819 MEDRAD, INC. MEDRAD VARIBLE INFUSION INJECTOR 09/16/1991
K982814 MEDRAD, INC. MEDRAD VISTRON CT INJECTOR SYSTEM 10/09/1998
K991557 MEDRAD, INC. MEDRAD VISTRON CT INJECTOR SYSTEM 07/21/1999
K011991 MEDRAD, INC. MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR 08/21/2001
K012950 MEDRAD, INC. MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM 10/04/2001
K800823 MEDRAD, INC. QUICK FILL 04/29/1980
K984418 MEDRAD, INC. UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET 03/11/1999
K132928 MEDRAD, INC. / BAYER MEDICAL CARE, INC. MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE 01/23/2014
K920135 MEDROYAL, INC. MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE 07/24/1992
K890898 MEDTRONIC VERSAFLEX, INC. MODEL 611101 CONTRAST INJECTION DEVICE 04/12/1989
K160107 Merit Medical Systems, Inc. DiamondTOUCH Inflation Device and Fluid Dispensing Syringe 07/29/2016
K163084 Merit Medical Systems, Inc. Merit Coronary Control Syringe 06/15/2017
K884913 MERIT MEDICAL SYSTEMS, INC. MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) 04/18/1989
K973230 MERIT MEDICAL SYSTEMS, INC. MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) 11/25/1997
K083523 MERIT MEDICAL SYSTEMS, INC. MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE 02/04/2009
K011811 MERIT MEDICAL SYSTEMS, INC. MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE 08/22/2001
K932083 MICROWAVE MEDICAL SYSTEMS, INC. XDCS-100 12/16/1993
K113198 NAVILYST MEDICAL, INC. NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML 11/28/2011
K062168 NEMOTO KYORINDO CO., LTD. CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA 08/18/2006
K052633 NEMOTO KYORINDO CO., LTD. DUAL SHOT - CONTRAST DELIVERY SYSTEM 10/17/2005
K071691 NEMOTO KYORINDO CO., LTD. DUAL SHOT ALPHA 12/19/2007
K133189 NEMOTO KYORINDO CO., LTD. DUAL SHOT ALPHA 7 06/30/2014
K173450 Nemoto Kyorindo Co., Ltd. PRESS DUO elite, PRESS DUO elite AG 02/07/2018
K092896 NEMOTO KYORINDO CO., LTD. REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS 10/29/2010
K873955 NORTH AMERICAN INSTRUMENT CORP. NAMIC ANGIOGRAPHIC SYRINGE 02/05/1988
K152218 Osprey Medical AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System 09/21/2015
K151300 OSPREY MEDICAL, INC. AVERT Contrast Modulation System 10/15/2015
K150485 Osprey Medical, Inc. AVERT Contrast Modulation System 03/26/2015
K131478 OSPREY MEDICAL, INC. CONTRAST CONSERVATION SYSTEM 08/15/2013
K140425 OSPREY MEDICAL, INC. CONTRAST MODULATION SYSTEM 06/11/2014
K142081 OSPREY MEDICAL, INC. CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES 12/12/2014
K151746 OSPREY MEDICAL, INC. Dyevert Contrast Modulation System 10/09/2015
K153141 OSPREY MEDICAL, INC. DyeVert Contrast Modulation System 02/04/2016
K161505 OSPREY MEDICAL, INC. DyeVert NG Contrast Modulation System 08/03/2016
K163054 OSPREY MEDICAL, INC. DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System 03/08/2017
K171217 Osprey Medical, Inc. DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System 05/26/2017
K171698 Osprey Medical, Inc. Smart Syringe 07/07/2017
K875324 SCHNEIDER-SHILLEY (USA) MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES 03/25/1988
K960430 SCIENTIFIC DEVICE MANUFACTURER LLC. CONTROL SYRINGE 08/06/1996
K951802 SCIMED LIFE SYSTEMS, INC. SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT 07/21/1995
K082439 SHANDONG WEIGAO MEDICAL POLYMER CO., LTD 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 03/23/2009
K170025 SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. Angiography Syringe 10/03/2017
K170014 SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. High Pressure Tubing 10/06/2017
K172694 Shenyang MasTech Medical Device Co., Ltd. Sterile Disposable Syringes 07/06/2018
K072696 SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 05/02/2008
K151960 SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD Sterile High-pressure Angiographic Syringes for Single-use 01/07/2016
K160190 Sunny Medical Device (Shenzhen) Co.,Ltd. Sunmed Control Syringes 11/10/2016
K833138 SYBRON CORP. DIGITAL INJECTOR SYS 11/14/1983
K860842 TARGET THERAPEUTICS ANGIOJECT 04/23/1986
K911549 THE R GROUP INJECTOR FILL TUBE 07/18/1991
K061976 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. CKIS-004A INJECTOR SYNCHRONIZATION OPTION 09/27/2006
K841092 TRONOMED, INC. HIGH PRESSURE FLEX. CONNECTING TUBING 07/24/1985
K983826 UNIMACHS CORP. 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM 03/23/2000
K170279 Union Medical Shenzhen Co., Ltd. Disposable High Pressure Syringe 12/12/2017
K823190 VERTEX MEDICAL CORP. BACKSTOP VALVE W/SIDE ARM 12/30/1982
K823340 VERTEX MEDICAL CORP. CLEAR VINYL MONITORING CONNECTOR 12/30/1982
K823191 VERTEX MEDICAL CORP. DISPOSABLE PLASTIC STOPCOCK 12/30/1982
K823254 VERTEX MEDICAL CORP. REUSABLE METAL STOPCOCK 12/30/1982
K823192 VERTEX MEDICAL CORP. TUOHY-BORST ADAPTER W/SIDE ARM 12/30/1982
K823256 VERTEX MEDICAL CORP. ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE 12/30/1982
K823253 VERTEX MEDICAL CORP. VERTEX MONITORING CATHETER 12/30/1982
K823238 VETREX MEDICAL CORP. INJECTION FILL TUBE 12/30/1982
K152906 WUXI YUSHOU MEDICAL APPLICANCES CO., LTD Disposable High Pressure Injector Syringe 11/22/2016


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