FDA 510(k)

AMSafe(R) Pre-Filled Normal Saline Flush Syringe

Número K: K183473 · 2019-07-12

Data da decisão2019-07-12

Código do produtoNGT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

AMSafe(R) 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 2019-07-12 under 510(k) number K183473. 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(R) Pre-Filled Normal Saline Flush Syringe?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Amsino International, Inc.. The 510(k) number is K183473.

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

AMSafe(R) Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2019-07-12, under 510(k) number K183473.

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

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

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K213522AMSafe Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set K181445AMSure Hydrophilic Intermittent Catheter

Ver todos os 11 dispositivos →

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.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.