FDA 510(k)

Sterile High-pressure Angiographic Syringes for Single-use

N.º K: K151960 · 2016-01-07

SolicitanteShenzhen Baoan Medical Supplies Co., Ltd.

Fecha de decisión2016-01-07

Código de productoDXT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile High-pressure Angiographic Syringes for Single-use is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Baoan Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K151960. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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 2016-01-07. The listed applicant is Shenzhen Baoan Medical Supplies Co., Ltd.. The 510(k) number is K151960.

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 2016-01-07, under 510(k) number K151960.

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

The FDA 510(k) record lists Shenzhen Baoan Medical Supplies 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.

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Otros registros que enlistan a Shenzhen Baoan Medical Supplies Co., Ltd. como solicitante

K182289Sterile High-pressure Angiographic Syringes for Single-use

Dispositivos relacionados (Código: 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 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.K252653Sistema de Diagnóstico ACIST Pro (019304); Unidad de Procesamiento Montada en Cama; Módulo AngioTouch; Carro ACIST Pro; Cable de Transductor Único; Cable de Transductor TripleAcist 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.

Fuente oficial

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