FDA Product Code
FDA Product Code DXT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1650
510(k) Clearances — 210 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | Fortis Biosolutions Company Limited | 2026-05-14 | Traditional | PDF ↗ |
| K252638 | 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) | Acist Medical Systems, Inc. | 2026-05-13 | Traditional | PDF ↗ |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | Acist Medical Systems, Inc. | 2026-05-13 | Traditional | PDF ↗ |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | 2026-04-16 | Traditional | PDF ↗ |
| K251788 | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | 2026-03-05 | Traditional | PDF ↗ |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | 2026-02-13 | Traditional | PDF ↗ |
| K244038 | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | 2025-09-05 | Traditional | PDF ↗ |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | 2024-12-23 | Traditional | PDF ↗ |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | 2024-08-27 | Traditional | PDF ↗ |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. | 2024-08-22 | Traditional | PDF ↗ |
| K230668 | Disposable High-pressure Extension Lines | Precision Medical Plastics , Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K232388 | High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd | 2023-11-21 | Traditional | PDF ↗ |
| K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2021-10-19 | Traditional | PDF ↗ |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | 2020-12-17 | Special | PDF ↗ |
| K201395 | Sterile High-pressure Angiographic Syringes for single-use | Youwo (Guangzhou) Medical Device Co., Ltd. | 2020-10-28 | Traditional | PDF ↗ |
| K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2020-08-07 | Traditional | PDF ↗ |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | Bayer Medical Care, Inc. | 2019-12-13 | Traditional | PDF ↗ |
| K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | 2019-12-05 | Special | PDF ↗ |
| K190102 | DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System | Osprey Medical, Inc. | 2019-10-17 | Traditional | PDF ↗ |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | Acist Medical Systems, Inc. | 2019-07-18 | Traditional | PDF ↗ |
| K183267 | DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | 2018-12-20 | Special | PDF ↗ |
| K182273 | 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 | Bayer Medical Care, Inc. | 2018-11-01 | Special | PDF ↗ |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | Bayer Medical Care, Inc. | 2018-11-01 | Special | PDF ↗ |
| K181936 | DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | 2018-10-25 | Special | PDF ↗ |
| K182289 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2018-10-10 | Special | PDF ↗ |
| K173773 | 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 | Bayer Medical Care, Inc. | 2018-08-17 | Traditional | PDF ↗ |
| K172694 | Sterile Disposable Syringes | Shenyang Mastech Medical Device Co., Ltd. | 2018-07-06 | Traditional | PDF ↗ |
| K171646 | ACISTCVi® Contrast Delivery System | Acist Medical Systems, Inc. | 2018-02-16 | Traditional | PDF ↗ |
| K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018-02-07 | Traditional | PDF ↗ |
| K170279 | Disposable High Pressure Syringe | Union Medical Shenzhen Co., Ltd. | 2017-12-12 | Traditional | PDF ↗ |
| K170431 | 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 | Coeur, Inc. | 2017-08-18 | Traditional | PDF ↗ |
| K171698 | Smart Syringe | Osprey Medical, Inc. | 2017-07-07 | Special | PDF ↗ |
| K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | 2017-06-15 | Abbreviated | PDF ↗ |
| K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System | Osprey Medical, Inc. | 2017-05-26 | Special | PDF ↗ |
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System | Osprey Medical, Inc. | 2017-03-08 | Traditional | PDF ↗ |
| K162088 | Ecomed Disposable Angiographic Syringes | Ecomed Solutions, LLC | 2017-01-27 | Traditional | PDF ↗ |
| K152906 | Disposable High Pressure Injector Syringe | Wuxi Yushou Medical Appliances Co., Ltd. | 2016-11-22 | Traditional | PDF ↗ |
| K160190 | Sunmed Control Syringes | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-11-10 | Traditional | PDF ↗ |
| K161471 | MR Syringe Dual Pack for Solaris Injectors | Coeur, Inc. | 2016-10-06 | Traditional | PDF ↗ |
| K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | 2016-08-03 | Special | PDF ↗ |
| K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2016-07-29 | Traditional | PDF ↗ |
| K152978 | DeRoyal Angiography Kits | Deroyal Industries, Inc. | 2016-03-25 | Traditional | PDF ↗ |
| K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016-02-04 | Traditional | PDF ↗ |
| K151960 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016-01-07 | Traditional | PDF ↗ |
| K150902 | 330psi Extension Y-Line with Dual Check Valve | Coeur, Inc. | 2015-10-22 | Traditional | PDF ↗ |
| K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015-10-15 | Traditional | PDF ↗ |
| K151746 | Dyevert Contrast Modulation System | Osprey Medical, Inc. | 2015-10-09 | Traditional | PDF ↗ |
| K152218 | AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System | Osprey Medical | 2015-09-21 | Traditional | PDF ↗ |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | Bayer Medical Care, Inc. | 2015-08-14 | Traditional | PDF ↗ |
| K142745 | 125mL CT Syringe | Coeur, Inc. | 2015-04-01 | Traditional | PDF ↗ |
| K150485 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015-03-26 | Special | PDF ↗ |
| K142081 | CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES | Osprey Medical, Inc. | 2014-12-12 | Traditional | PDF ↗ |
| K140469 | MR SYRINGE DUAL PACK | Coeur, Inc. | 2014-07-28 | Traditional | PDF ↗ |
| K133189 | DUAL SHOT ALPHA 7 | Nemoto Kyorindo Co., Ltd. | 2014-06-30 | Special | PDF ↗ |
| K140425 | CONTRAST MODULATION SYSTEM | Osprey Medical, Inc. | 2014-06-11 | Traditional | PDF ↗ |
| K133600 | COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR | Coeur, Inc. | 2014-04-30 | Traditional | PDF ↗ |
| K132928 | MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE | Medrad, Inc. / Bayer Medical Care, Inc. | 2014-01-23 | Special | PDF ↗ |
| K131478 | CONTRAST CONSERVATION SYSTEM | Osprey Medical, Inc. | 2013-08-15 | Traditional | PDF ↗ |
| K120892 | DISPOSABLE 330PSI EXTENSION LINES | Coeur, Inc. | 2013-06-10 | Traditional | PDF ↗ |
| K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE | Medrad, Inc. | 2011-12-15 | Special | PDF ↗ |
| K113198 | NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML | Navilyst Medical, Inc. | 2011-11-28 | Special | PDF ↗ |
| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | Medrad, Inc. | 2011-10-14 | Special | PDF ↗ |
| K093830 | MEDLINE ANGIOGRAPHIC CONTROL SYRINGE | Medline Industries, Inc. | 2011-03-03 | Traditional | PDF ↗ |
| K092896 | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS | Nemoto Kyorindo Co., Ltd. | 2010-10-29 | Traditional | PDF ↗ |
| K090487 | DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 | Coeur, Inc. | 2009-10-19 | Traditional | PDF ↗ |
| K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 | Flowcardia, Inc. | 2009-06-19 | Traditional | PDF ↗ |
| K082439 | 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 | Shandong Weigao Medical Polymer Co., Ltd. | 2009-03-23 | Traditional | PDF ↗ |
| K083523 | MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE | Merit Medical Systems, Inc. | 2009-02-04 | Special | PDF ↗ |
| K082212 | SYRINGE WITH HANDI-FIL | Mallinckrodt Inc., Liebel-Flarsheim Business | 2009-01-22 | Special | PDF ↗ |
| K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC | Medrad, Inc. | 2009-01-12 | Traditional | PDF ↗ |
| K073592 | OPTISTAR ELITE INJECTION SYSTEM | Mallinckrodt Inc., Liebel-Flarsheim Business | 2008-05-07 | Traditional | PDF ↗ |
| K072696 | ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008-05-02 | Traditional | PDF ↗ |
| K072886 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T | Medrad, Inc. | 2007-12-21 | Traditional | PDF ↗ |
| K071691 | DUAL SHOT ALPHA | Nemoto Kyorindo Co., Ltd. | 2007-12-19 | Special | PDF ↗ |
| K070798 | ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS | Coeur, Inc. | 2007-10-04 | Traditional | PDF ↗ |
| K061976 | CKIS-004A INJECTOR SYNCHRONIZATION OPTION | Toshiba America Medical Systems, In.C | 2006-09-27 | Traditional | PDF ↗ |
| K062168 | CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA | Nemoto Kyorindo Co., Ltd. | 2006-08-18 | Traditional | PDF ↗ |
| K052744 | C2000 AUTOMATED MANIFOLD KIT | Acist Medical Systems, Inc. | 2005-12-16 | Special | PDF ↗ |
| K051799 | DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS | Coeur, Inc. | 2005-11-02 | Traditional | PDF ↗ |
| K052633 | DUAL SHOT - CONTRAST DELIVERY SYSTEM | Nemoto Kyorindo Co., Ltd. | 2005-10-17 | Traditional | PDF ↗ |
| K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM | Medrad, Inc. | 2005-06-17 | Traditional | PDF ↗ |
| K042784 | MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM | Medrad, Inc. | 2004-12-10 | Special | PDF ↗ |
| K042744 | OPTIV ANTAGE DH POWER INJECTION SYSTEM | Mallinckrodt Inc., Liebel-Flarsheim Business | 2004-11-30 | Special | PDF ↗ |
| K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS | Acist Medical Systems, Inc. | 2004-03-15 | Special | PDF ↗ |
| K033881 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE | Medrad, Inc. | 2004-03-02 | Special | PDF ↗ |
| K032920 | THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 | Coeur Medical | 2003-12-16 | Traditional | PDF ↗ |
| K033247 | MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM | Medrad, Inc. | 2003-11-05 | Special | PDF ↗ |
| K031483 | MEDRAD MANUAL SYRINGE LOADER | Medrad, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K031339 | OPTIBOLUS | Mallinckrodt Inc., Liebel-Flarsheim Business | 2003-07-11 | Special | PDF ↗ |
| K020892 | ACIST GENTOO CONTRAST INJECTION SYSTEM | Acist Medical Systems | 2003-01-27 | Abbreviated | PDF ↗ |
| K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM | Medrad, Inc. | 2003-01-10 | Special | PDF ↗ |
| K022116 | ELPH INJECTION SYSTEM | Mallinckrodt Inc., Liebel-Flarsheim Business | 2002-07-26 | Special | PDF ↗ |
| K020333 | ATRION MEDICAL QL FLUID DISPENSING SYRINGE | Atrion Medical Products, Inc. | 2002-04-25 | Traditional | PDF ↗ |
| K013815 | MEDRAD QWIK-FIT SYRINGE | Medrad, Inc. | 2001-12-13 | Special | PDF ↗ |
| K012950 | MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM | Medrad, Inc. | 2001-10-04 | Special | PDF ↗ |
| K011811 | MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE | Merit Medical Systems, Inc. | 2001-08-22 | Special | PDF ↗ |
| K011991 | MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR | Medrad, Inc. | 2001-08-21 | Special | PDF ↗ |
| K010390 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS | Acist Medical Systems, Inc. | 2001-03-09 | Special | PDF ↗ |
| K001663 | FRONT-LOAD POLYPROPYLENE SYRINGE | Medrad, Inc. | 2000-11-16 | Traditional | PDF ↗ |
| K991103 | MODIFICATION TO ACIST CL 100H | Acist Medical Systems | 2000-05-31 | Traditional | PDF ↗ |
Product code DXT · Class II · Cardiovascular. Data: openFDA.