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510(k) K241109

Device
Single-use Sterile High-pressure Angiographic Syringes and Accessories
Applicant
Shenzhen Boon Medical Supply Co., Ltd.
510(k) number
K241109
Product code
DXT
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-22
Date received
2024-04-22
Regulation
870.1650
Classification name
Injector And Syringe, Angiographic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shengyu Fan
Address
#18 Jirong Rd., Shenkeng, Henggang St. Longgang District Shenzhen CN 518173 518173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252652Disposable 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 SyrFortis Biosolutions Company Limited2026-05-14
K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.2026-05-13
K252638VeraPro 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
K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.2026-04-16
K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.2026-03-05
K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.2026-02-13
K244038High Pressure TubingShandong Int Medical Instruments Co., Ltd.2025-09-05
K242143Angiography InjectorShandong Int Medical Instruments Co., Ltd.2024-12-23
K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd.2024-08-27
K230668Disposable High-pressure Extension LinesPrecision Medical Plastics , Ltd.2024-06-14
K232388High Pressure TubingNingbo Dizegens Medical Science Co.,Ltd2023-11-21
K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.2021-10-19
K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemAcist Medical Systems, Inc.2020-12-17
K201395Sterile High-pressure Angiographic Syringes for single-useYouwo (Guangzhou) Medical Device Co., Ltd.2020-10-28
K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.2020-08-07