FDA 510(k)

Safety Subcutaneous Infusion Set

Número K: K201626 · 2021-03-24

Data da decisão2021-03-24

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Safety Subcutaneous Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K201626. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Safety Subcutaneous Infusion Set?

Safety Subcutaneous Infusion Set is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K201626.

When did Safety Subcutaneous Infusion Set receive FDA 510(k) clearance?

Safety Subcutaneous Infusion Set received FDA 510(k) clearance on 2021-03-24, under 510(k) number K201626.

Who is the listed applicant for Safety Subcutaneous Infusion Set?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Subcutaneous Infusion Set?

The FDA product code for Safety Subcutaneous Infusion Set is FPA.

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 Epic Medical Pte. , Ltd. como candidato(a)

K252987ADRx® Admixture Device K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)K251722ProSeal™ Transfer Injector (421120, 421130, 421140)K251814EZ™ IV Administration Set K252094eZSURE™ Empty Fluid Container K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

Ver todos os 22 dispositivos →

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)

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.