FDA 510(k)

Disposable IV catheter

N.º K: K202060 · 2021-07-23

SolicitanteShinva Ande Healthcare Apparatus Co., Ltd.

Fecha de decisión2021-07-23

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable IV catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K202060. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable IV catheter?

Disposable IV catheter is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K202060.

When did Disposable IV catheter receive FDA 510(k) clearance?

Disposable IV catheter received FDA 510(k) clearance on 2021-07-23, under 510(k) number K202060.

Who is the listed applicant for Disposable IV catheter?

The FDA 510(k) record lists Shinva Ande Healthcare Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable IV catheter?

The FDA product code for Disposable IV catheter is FOZ.

Ensayos clínicos relacionados

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Otros registros que enlistan a Shinva Ande Healthcare Apparatus Co., Ltd. como solicitante

K201460Closed System Transfer Device K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles K193657Disposable Enteral Feeding Syringe with Enfit Connector K162601Infusion Set for Single Use

Dispositivos relacionados (Código: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Fuente oficial

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