Product code DXT

Device name: Injector And Syringe, Angiographic
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.1650
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
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 Accessor...	Fortis Biosolutions Company Limited	2026-05-14
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
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 Ha...	Acist Medical Systems, Inc.	2026-05-13
K253048	High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube	Shenzhen Maiwei Biotech Co., Ltd.	2026-04-16
K251788	Extension tube	Zhuhai DR Medical Instruments Co., Ltd.	2026-03-05
K252891	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)	Bayer Medical Care, Inc.	2026-02-13
K244038	High Pressure Tubing	Shandong Int Medical Instruments Co., Ltd.	2025-09-05
K242143	Angiography Injector	Shandong Int Medical Instruments Co., Ltd.	2024-12-23
K242212	Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)	Nemoto Kyorindo Co., Ltd.	2024-08-27
K241109	Single-use Sterile High-pressure Angiographic Syringes and Accessories	Shenzhen Boon Medical Supply Co., Ltd.	2024-08-22
K230668	Disposable High-pressure Extension Lines	Precision Medical Plastics , Ltd.	2024-06-14
K232388	High Pressure Tubing	Ningbo Dizegens Medical Science Co.,Ltd	2023-11-21
K211564	Sterile High-pressure Angiographic Syringes for Single-use	Shenzhen Boon Medical Supply Co., Ltd.	2021-10-19
K203004	ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System	Acist Medical Systems, Inc.	2020-12-17
K201395	Sterile High-pressure Angiographic Syringes for single-use	Youwo (Guangzhou) Medical Device Co., Ltd.	2020-10-28
K192657	Sterile High-pressure Angiographic Syringes for Single-use	Shenzhen Boon Medical Supply Co., Ltd.	2020-08-07
K192370	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation	Bayer Medical Care, Inc.	2019-12-13
K193028	MEDRAD Mark 7 Arterion Injection System	Bayer Medical Care, Inc.	2019-12-05
K190102	DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System	Osprey Medical, Inc.	2019-10-17
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
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
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 Car...	Bayer Medical Care, Inc.	2018-11-01
K182276	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit	Bayer Medical Care, Inc.	2018-11-01
K181936	DyeVert PLUS EZ Contrast Reduction System	Osprey Medical, Inc.	2018-10-25
K182289	Sterile High-pressure Angiographic Syringes for Single-use	Shenzhen Baoan Medical Supplies Co., Ltd.	2018-10-10
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 Car...	Bayer Medical Care, Inc.	2018-08-17
K172694	Sterile Disposable Syringes	Shenyang Mastech Medical Device Co., Ltd.	2018-07-06
K171646	ACISTCVi® Contrast Delivery System	Acist Medical Systems, Inc.	2018-02-16
K173450	PRESS DUO elite, PRESS DUO elite AG	Nemoto Kyorindo Co., Ltd.	2018-02-07
K170279	Disposable High Pressure Syringe	Union Medical Shenzhen Co., Ltd.	2017-12-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
H965700850050	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700980030	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700971070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700970070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700970030	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700951070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700950070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700950030	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700880070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700880030	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700871070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700870070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700870030	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700851070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700850070	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H74904494100	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700850040	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700850030	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700750270	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H965700750230	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H749700270900	NAMIC	NAVILYST MEDICAL, INC.	2016-09-20
H749805062030	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749805051030	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749800970030	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749800951070	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749800950030	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749800870070	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749800870030	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749800750270	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17
H749800750230	NAMIC	NAVILYST MEDICAL, INC.	2015-09-17

Product code DXT

Related 510(k) Records#

Related GUDID Devices#