Avenu Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle, Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Avenu Medical, Inc. Cardiovascular ✕
3 devices
Cleared
Jan 25, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys...
Cardiovascular
30d
Cleared
Oct 05, 2018
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model...
Cardiovascular
98d
Not Cleared
Jun 22, 2018
Ellipsys Vascular Access System
Cardiovascular
528d