FDA 510(k) Applications Submitted by Avenu Medical, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K183615 12/26/2018 Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle Avenu Medical, Inc.
K181725 06/29/2018 Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) Avenu Medical, Inc.


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