Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Irras USA, Inc.

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

Total Devices2
Categories1
Latest FDA decision2023-10-19
TypeNumberDevice NameCodeDateActions
510(k) K231664 IRRAflow Active Fluid Exchange System (AFES)JXG2023-10-19 View
510(k) K200807 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitJXG2020-04-29 View