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FDA 510(k)

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

Número K: K191114 · 2019-08-09

RequerenteAvenu Medical
Data da decisão2019-08-09
Código do produtoPQK
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle is the device name listed in this FDA 510(k) record. The listed applicant is Avenu Medical. It received FDA 510(k) clearance on 2019-08-09 under 510(k) number K191114. The device is classified under product code PQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle?

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is Avenu Medical. The 510(k) number is K191114.

When did Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle receive FDA 510(k) clearance?

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle received FDA 510(k) clearance on 2019-08-09, under 510(k) number K191114.

Who is the listed applicant for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle?

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

What is the FDA product code for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle?

The FDA product code for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle is PQK.

Ensaios clínicos relacionados

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Dispositivos Relacionados (Código: PQK)

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.

K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc.K182796WavelinQ 4F EndoAVF SystemC.R. Bard, Inc.K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing NeedleAvenu Medical, Inc.K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)Avenu Medical, Inc.

Fonte oficial

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