FDA 510(k)

IRRAflow Active Fluid Exchange System (AFES)

K-Number: K231664 · 2023-10-19

Decision Date2023-10-19

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

IRRAflow Active Fluid Exchange System (AFES) is a medical device manufactured by Irras USA, Inc.. It received FDA 510(k) clearance on 2023-10-19 under approval number K231664. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRAflow Active Fluid Exchange System (AFES)?

IRRAflow Active Fluid Exchange System (AFES) is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Irras USA, Inc.. The 510(k) number is K231664.

When was IRRAflow Active Fluid Exchange System (AFES) approved by the FDA?

IRRAflow Active Fluid Exchange System (AFES) received FDA 510(k) clearance on 2023-10-19, under approval number K231664.

What company makes IRRAflow Active Fluid Exchange System (AFES)?

IRRAflow Active Fluid Exchange System (AFES) is manufactured by Irras USA, Inc..

What is the FDA product code for IRRAflow Active Fluid Exchange System (AFES)?

The FDA product code for IRRAflow Active Fluid Exchange System (AFES) is JXG.

Related Clinical Trials

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Other Devices by Irras USA, Inc.

K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Related Devices (Code: JXG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.