FDA 510(k)

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

N.º K: K181725 · 2018-10-05

Fecha de decisión2018-10-05

Código de productoPQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) is the device name listed in this FDA 510(k) record. The listed applicant is Avenu Medical, Inc.. It received FDA 510(k) clearance on 2018-10-05 under 510(k) number K181725. The device is classified under product code PQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)?

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) is a medical device that received FDA 510(k) clearance on 2018-10-05. The listed applicant is Avenu Medical, Inc.. The 510(k) number is K181725.

When did Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) receive FDA 510(k) clearance?

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) received FDA 510(k) clearance on 2018-10-05, under 510(k) number K181725.

Who is the listed applicant for Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)?

The FDA 510(k) record lists Avenu Medical, Inc. 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 Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)?

The FDA product code for Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) is PQK.

Ensayos clínicos relacionados

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Otros registros que enlistan a Avenu Medical, Inc. como solicitante

K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle

Dispositivos relacionados (Código: PQK)

K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc.K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), NeedleAvenu Medical 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.

Fuente oficial

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