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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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