Medical Device Manufacturer · US , San Diego , CA

Irras USA, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Irras USA, Inc. Neurology ✕
2 devices
1-2 of 2
Cleared Oct 19, 2023
IRRAflow Active Fluid Exchange System (AFES)
K231664 · JXG
Neurology · 134d
Cleared Apr 29, 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K200807 · JXG
Neurology · 33d
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