Avenu Medical

FDA Regulatory Profile

Avenu Medical appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 9, 2019.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access SystemAugust 9, 2019
K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access SystemJanuary 25, 2019
K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter &October 5, 2018
DEN170004Ellipsys Vascular Access SystemJune 22, 2018