FDA 510(k)

AMSafe Pre-Filled Normal Saline Flush Syringe

Número K: K213522 · 2022-03-22

Data da decisão2022-03-22

Código do produtoNGT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

AMSafe Pre-Filled Normal Saline Flush Syringe 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 2022-03-22 under 510(k) number K213522. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AMSafe Pre-Filled Normal Saline Flush Syringe?

AMSafe Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Amsino International, Inc.. The 510(k) number is K213522.

When did AMSafe Pre-Filled Normal Saline Flush Syringe receive FDA 510(k) clearance?

AMSafe Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2022-03-22, under 510(k) number K213522.

Who is the listed applicant for AMSafe Pre-Filled Normal Saline Flush Syringe?

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 Pre-Filled Normal Saline Flush Syringe?

The FDA product code for AMSafe Pre-Filled Normal Saline Flush Syringe is NGT.

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Outros registros que listam Amsino International, Inc. como candidato(a)

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 K200051PUGGLE Enteral Feeding Pump and Feeding Set K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe K181445AMSure Hydrophilic Intermittent Catheter

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Dispositivos Relacionados (Código: NGT)

K250884Injeção de Sódio Clorídrico 0,9 %, USP, Siringa BD PosiFlush™ SPBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.

Fonte oficial

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