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FDA 510(k)

Disposable High Pressure Injector Syringe

K-Number: K152906 · 2016-11-22

ApplicantWuxi Yushou Medical Appliances Co., Ltd.
Decision Date2016-11-22
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable High Pressure Injector Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Yushou Medical Appliances Co., Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K152906. 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 Disposable High Pressure Injector Syringe?

Disposable High Pressure Injector Syringe is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Wuxi Yushou Medical Appliances Co., Ltd.. The 510(k) number is K152906.

When did Disposable High Pressure Injector Syringe receive FDA 510(k) clearance?

Disposable High Pressure Injector Syringe received FDA 510(k) clearance on 2016-11-22, under 510(k) number K152906.

Who is the listed applicant for Disposable High Pressure Injector Syringe?

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

What is the FDA product code for Disposable High Pressure Injector Syringe?

The FDA product code for Disposable High Pressure Injector Syringe is DXT.

Other records listing Wuxi Yushou Medical Appliances 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.

K210679Medical Face Mask

Related Devices (Code: DXT)

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.

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 LimitedK252653ACIST 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

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

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