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FDA 510(k)

IRRAflow Active Fluid Exchange System (AFES)

K-Number: K222471 · 2022-12-08

ApplicantIrras USA
Decision Date2022-12-08
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IRRAflow Active Fluid Exchange System (AFES) is the device name listed in this FDA 510(k) record. The listed applicant is Irras USA. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K222471. 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 2022-12-08. The listed applicant is Irras USA. The 510(k) number is K222471.

When did IRRAflow Active Fluid Exchange System (AFES) receive FDA 510(k) clearance?

IRRAflow Active Fluid Exchange System (AFES) received FDA 510(k) clearance on 2022-12-08, under 510(k) number K222471.

Who is the listed applicant for IRRAflow Active Fluid Exchange System (AFES)?

The FDA 510(k) record lists Irras USA as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Irras USA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231664IRRAflow Active Fluid Exchange System (AFES)K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitK192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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