FDA 510(k)

Intellifuse Administration and Intellifuse Blood Administration Sets

Número K: K192375 · 2020-09-18

Data da decisão2020-09-18

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intellifuse Administration and Intellifuse Blood Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K192375. 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 Intellifuse Administration and Intellifuse Blood Administration Sets?

Intellifuse Administration and Intellifuse Blood Administration Sets is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K192375.

When did Intellifuse Administration and Intellifuse Blood Administration Sets receive FDA 510(k) clearance?

Intellifuse Administration and Intellifuse Blood Administration Sets received FDA 510(k) clearance on 2020-09-18, under 510(k) number K192375.

Who is the listed applicant for Intellifuse Administration and Intellifuse Blood Administration Sets?

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

What is the FDA product code for Intellifuse Administration and Intellifuse Blood Administration Sets?

The FDA product code for Intellifuse Administration and Intellifuse Blood Administration Sets 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 Smiths Medical Asd, Inc. como candidato(a)

K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula K211634Hypodermic Needle-Pro EDGE Safety Device K181699Level 1 Convective Warmer K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors K172823Portex NRFit Epidural Needles

Ver todos os 16 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.