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

FDA 510(k) K181725 · Avenu Medical, Inc.

Substantially Equivalent

510(k) numberK181725

Submission

Device name
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
Applicant
Avenu Medical, Inc.
San Juan Capistrano, CA, US
Received
June 29, 2018
Decision date
October 5, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PQK – Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1252
Specialty
Cardiovascular

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

Other 510(k)s with product code PQK

510(k)DeviceApplicantDecision
K192239WavelinQ Plus EndoAVF SystemPQK · Traditional C.R. Bard, Inc.10/17/2019SE
K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…PQK · Traditional Avenu Medical08/09/2019SE
K182796WavelinQ 4F EndoAVF SystemPQK · Traditional C.R. Bard, Inc.02/06/2019SE
K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…PQK · Special Avenu Medical, Inc.01/25/2019SE

More from Avenu Medical, Inc.

510(k)DeviceDecision
K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…PQK · Traditional 08/09/2019SE
K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…PQK · Special 01/25/2019SE

Questions and answers

When was Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) cleared by the FDA?

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (K181725) received a 510(k) decision of Substantially Equivalent on October 5, 2018, 98 days after the submission was received.

What is the product code of K181725?

The FDA product code is PQK – Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access, a Class II (moderate risk) device regulated under 21 CFR 870.1252.