Irras USA, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K231664IRRAflow Active Fluid Exchange System (AFES)October 19, 2023
K222471IRRAflow Active Fluid Exchange System (AFES)December 8, 2022
K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitApril 29, 2020
K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitNovember 15, 2019