FDA 510(k)

Sterile High-pressure Angiographic Syringes for Single-use

K-Number: K192657 · 2020-08-07

ApplicantShenzhen Boon Medical Supply Co., Ltd.

Decision Date2020-08-07

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sterile High-pressure Angiographic Syringes for Single-use is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K192657. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile High-pressure Angiographic Syringes for Single-use?

Sterile High-pressure Angiographic Syringes for Single-use is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. The 510(k) number is K192657.

When did Sterile High-pressure Angiographic Syringes for Single-use receive FDA 510(k) clearance?

Sterile High-pressure Angiographic Syringes for Single-use received FDA 510(k) clearance on 2020-08-07, under 510(k) number K192657.

Who is the listed applicant for Sterile High-pressure Angiographic Syringes for Single-use?

The FDA 510(k) record lists Shenzhen Boon Medical Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile High-pressure Angiographic Syringes for Single-use?

The FDA product code for Sterile High-pressure Angiographic Syringes for Single-use is DXT.

Other records listing Shenzhen Boon Medical Supply Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241109Single-use Sterile High-pressure Angiographic Syringes and Accessories K211564Sterile High-pressure Angiographic Syringes for Single-use

Related Devices (Code: DXT)

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 Limited K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.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.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.