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..

210
Total
210
Cleared
146d
Avg days
1978
Since
210 devices
25–48 of 210
Cleared Oct 10, 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289
Shenzhen Baoan Medical Supplies Co., Ltd.
Cardiovascular · 48d
Cleared Aug 17, 2018
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
K173773
Bayer Medical Care, Inc.
Cardiovascular · 248d
Cleared Jul 06, 2018
Sterile Disposable Syringes
K172694
Shenyang Mastech Medical Device Co., Ltd.
Cardiovascular · 302d
Cleared Feb 16, 2018
ACISTCVi® Contrast Delivery System
K171646
Acist Medical Systems, Inc.
Cardiovascular · 256d
Cleared Feb 07, 2018
PRESS DUO elite, PRESS DUO elite AG
K173450
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 93d
Cleared Dec 12, 2017
Disposable High Pressure Syringe
K170279
Union Medical Shenzhen Co., Ltd.
Cardiovascular · 316d
Cleared Aug 18, 2017
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
K170431
Coeur, Inc.
Cardiovascular · 186d
Cleared Jul 07, 2017
Smart Syringe
K171698
Osprey Medical, Inc.
Cardiovascular · 29d
Cleared Jun 15, 2017
Merit Coronary Control Syringe
K163084
Merit Medical Systems, Inc.
Cardiovascular · 224d
Cleared May 26, 2017
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
K171217
Osprey Medical, Inc.
Cardiovascular · 30d
Cleared Mar 08, 2017
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
K163054
Osprey Medical, Inc.
Cardiovascular · 127d
Cleared Jan 27, 2017
Ecomed Disposable Angiographic Syringes
K162088
Ecomed Solutions, LLC
Cardiovascular · 183d
Cleared Nov 22, 2016
Disposable High Pressure Injector Syringe
K152906
Wuxi Yushou Medical Appliances Co., Ltd.
General Hospital · 418d
Cleared Nov 10, 2016
Sunmed Control Syringes
K160190
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular · 288d
Cleared Oct 06, 2016
MR Syringe Dual Pack for Solaris Injectors
K161471
Coeur, Inc.
Cardiovascular · 132d
Cleared Aug 03, 2016
DyeVert NG Contrast Modulation System
K161505
Osprey Medical, Inc.
Cardiovascular · 63d
Cleared Jul 29, 2016
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107
Merit Medical Systems, Inc.
Cardiovascular · 192d
Cleared Mar 25, 2016
DeRoyal Angiography Kits
K152978
Deroyal Industries, Inc.
Cardiovascular · 168d
Cleared Feb 04, 2016
DyeVert Contrast Modulation System
K153141
Osprey Medical, Inc.
Cardiovascular · 97d
Cleared Jan 07, 2016
Sterile High-pressure Angiographic Syringes for Single-use
K151960
Shenzhen Baoan Medical Supplies Co., Ltd.
Cardiovascular · 175d
Cleared Oct 22, 2015
330psi Extension Y-Line with Dual Check Valve
K150902
Coeur, Inc.
Cardiovascular · 202d
Cleared Oct 15, 2015
AVERT Contrast Modulation System
K151300
Osprey Medical, Inc.
Cardiovascular · 153d
Cleared Oct 09, 2015
Dyevert Contrast Modulation System
K151746
Osprey Medical, Inc.
Cardiovascular · 102d
Cleared Sep 21, 2015
AVERT Contrast Modulation System
K152218
Osprey Medical
Cardiovascular · 45d