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Avenu Medical, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories1
Latest FDA decision2019-01-25
TypeNumberDevice NameCodeDateActions
510(k) K183615 Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing NeedlePQK2019-01-25 View
510(k) K181725 Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)PQK2018-10-05 View