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FDA 510(k)

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

K-Number: K181725 · 2018-10-05

ApplicantAvenu Medical, Inc.
Decision Date2018-10-05
Product CodePQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Avenu Medical, Inc.. The 510(k) number is K181725.

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

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 approval number K181725.

What company makes 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 manufactured by Avenu Medical, Inc..

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.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 39925011 Is more data always better? On alternative policies to mitigate bias in Artificial Intelligence health systems. Bioethics (2025)

Other Devices by Avenu Medical, Inc.

DEN170004Ellipsys Vascular Access System K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle

Related Devices (Code: PQK)

DEN160006everlinQ endoAVF SystemTva Medical, Inc. DEN170004Ellipsys Vascular Access SystemAvenu Medical, Inc. 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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