FDA 510(k)

AMSafe Sure-Lok Needle-Free Connector

N.º K: K173665 · 2018-09-05

Fecha de decisión2018-09-05

Código de productoFPA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

AMSafe Sure-Lok Needle-Free Connector is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K173665. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AMSafe Sure-Lok Needle-Free Connector?

AMSafe Sure-Lok Needle-Free Connector is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Amsino International, Inc.. The 510(k) number is K173665.

When did AMSafe Sure-Lok Needle-Free Connector receive FDA 510(k) clearance?

AMSafe Sure-Lok Needle-Free Connector received FDA 510(k) clearance on 2018-09-05, under 510(k) number K173665.

Who is the listed applicant for AMSafe Sure-Lok Needle-Free Connector?

The FDA 510(k) record lists Amsino International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSafe Sure-Lok Needle-Free Connector?

The FDA product code for AMSafe Sure-Lok Needle-Free Connector is FPA.

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Otros registros que enlistan a Amsino International, Inc. como solicitante

K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure Enteral Feeding Pump K220267AMSafe NeuFlo Needleless Connector K213522AMSafe Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe

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Dispositivos relacionados (Código: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np Medical K250325BD Alaris Pump Infusion SetCarefusion (Bd)

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.