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

FDA 510(k) K183615 · Avenu Medical, Inc.

Substantially Equivalent

510(k) numberK183615

Submission

Device name
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
Applicant
Avenu Medical, Inc.
San Juan Capistrano, CA, US
Received
December 26, 2018
Decision date
January 25, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 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
K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001…PQK · Traditional Avenu Medical, Inc.10/05/2018SE

More from Avenu Medical, Inc.

510(k)DeviceDecision
K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…PQK · Traditional 08/09/2019SE
K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001…PQK · Traditional 10/05/2018SE

Questions and answers

When was Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle cleared by the FDA?

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (K183615) received a 510(k) decision of Substantially Equivalent on January 25, 2019, 30 days after the submission was received.

What is the product code of K183615?

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.