Irras USA

FDA Regulatory Profile

Irras USA 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 October 19, 2023.

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