Injector And Syringe, Angiographic
FDA product code DXT · 197 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1650
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1978-08-17 – 2026-05-14
DXT
2026-05-14
DXT
2026-05-13
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
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DXT
2026-05-13
VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)
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DXT
2026-04-16
High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
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DXT
2026-03-05
Extension tube
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DXT
2026-02-13
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
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DXT
2025-09-05
High Pressure Tubing
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DXT
2024-12-23
Angiography Injector
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DXT
2024-08-27
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
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DXT
2024-08-22
Single-use Sterile High-pressure Angiographic Syringes and Accessories
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DXT
2024-06-14
Disposable High-pressure Extension Lines
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DXT
2023-11-21
High Pressure Tubing
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DXT
2021-10-19
Sterile High-pressure Angiographic Syringes for Single-use
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DXT
2020-12-17
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
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DXT
2020-10-28
Sterile High-pressure Angiographic Syringes for single-use
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DXT
2020-08-07
Sterile High-pressure Angiographic Syringes for Single-use
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DXT
2019-12-13
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
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DXT
2019-12-05
MEDRAD Mark 7 Arterion Injection System
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DXT
2019-10-17
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System
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DXT
2019-07-18
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
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DXT
2018-12-20
DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
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DXT
2018-11-01
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
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DXT
2018-11-01
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 Abdomen, ISI, Connect.CT
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DXT
2018-10-25
DyeVert PLUS EZ Contrast Reduction System
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DXT
2018-10-10
Sterile High-pressure Angiographic Syringes for Single-use
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DXT
2018-08-17
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 Abdomen, ISI, Connect.CT
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DXT
2018-07-06
Sterile Disposable Syringes
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DXT
2018-02-16
ACISTCVi® Contrast Delivery System
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DXT
2018-02-07
PRESS DUO elite, PRESS DUO elite AG
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DXT
2017-12-12
Disposable High Pressure Syringe
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DXT
2017-08-18
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
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DXT
2017-07-07
Smart Syringe
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DXT
2017-06-15
Merit Coronary Control Syringe
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DXT
2017-05-26
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
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DXT
2017-03-08
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
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DXT
2017-01-27
Ecomed Disposable Angiographic Syringes
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DXT
2016-11-22
Disposable High Pressure Injector Syringe
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DXT
2016-11-10
Sunmed Control Syringes
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DXT
2016-10-06
MR Syringe Dual Pack for Solaris Injectors
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DXT
2016-08-03
DyeVert NG Contrast Modulation System
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DXT
2016-07-29
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
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DXT
2016-03-25
DeRoyal Angiography Kits
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DXT
2016-02-04
DyeVert Contrast Modulation System
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DXT
2016-01-07
Sterile High-pressure Angiographic Syringes for Single-use
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DXT
2013-08-15
CONTRAST CONSERVATION SYSTEM
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DXT
2013-06-10
DISPOSABLE 330PSI EXTENSION LINES
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DXT
2011-12-15
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
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DXT
2011-11-28
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
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DXT
2011-10-14
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
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DXT
2011-03-03
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
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DXT
2010-10-29
REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
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DXT
2009-10-19
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
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DXT
2009-06-19
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
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DXT
2009-03-23
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
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DXT
2009-02-04
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
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DXT
2009-01-22
SYRINGE WITH HANDI-FIL
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DXT
2009-01-12
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
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DXT
2008-05-07
OPTISTAR ELITE INJECTION SYSTEM
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DXT
2008-05-02
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
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DXT
2007-12-21
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
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DXT
2007-12-19
DUAL SHOT ALPHA
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DXT
2007-10-04
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
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DXT
2006-09-27
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
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DXT
2006-08-18
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
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DXT
2005-12-16
C2000 AUTOMATED MANIFOLD KIT
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DXT
2005-11-02
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
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DXT
2005-10-17
DUAL SHOT - CONTRAST DELIVERY SYSTEM
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DXT
2005-06-17
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
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DXT
2004-12-10
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
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DXT
2004-11-30
OPTIV ANTAGE DH POWER INJECTION SYSTEM
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DXT
2004-03-15
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
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DXT
2004-03-02
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
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DXT
2003-12-16
THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
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DXT
2003-11-05
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
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DXT
2003-08-01
MEDRAD MANUAL SYRINGE LOADER
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DXT
2003-07-11
OPTIBOLUS
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DXT
2003-01-27
ACIST GENTOO CONTRAST INJECTION SYSTEM
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DXT
2003-01-10
MEDRAD STELLANT CT INJECTOR SYSTEM
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DXT
2002-07-26
ELPH INJECTION SYSTEM
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DXT
2002-04-25
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
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DXT
2001-12-13
MEDRAD QWIK-FIT SYRINGE
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DXT
2001-10-04
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
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DXT
2001-08-22
MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
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DXT
2001-08-21
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
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DXT
2001-03-09
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
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DXT
2000-11-16
FRONT-LOAD POLYPROPYLENE SYRINGE
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DXT
2000-05-31
MODIFICATION TO ACIST CL 100H
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DXT
2000-05-31
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
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DXT
2000-03-28
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
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DXT
2000-03-23
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
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DXT
1999-12-07
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
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DXT
1999-12-06
OPTISTAR MR INJECTOR SYSTEM
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DXT
1999-11-26
MEDRAD ENVISION CT INJECTOR SYSTEM
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DXT
1999-07-21
MEDRAD VISTRON CT INJECTOR SYSTEM
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DXT
1999-03-11
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
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DXT
1998-10-09
MEDRAD VISTRON CT INJECTOR SYSTEM
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DXT
1998-04-03
OZ POWER SYRINGE
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DXT
1997-12-05
ACIST ANGIOGRAPHIC INJECTOR
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DXT
1997-11-25
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
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DXT
1997-10-08
COEUR 130 ML ANGIOGRAPHIC SYRINGE
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