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FDA 510(k)

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

K-Number: K192289 · 2019-11-15

ApplicantIrras USA, Ltd.
Decision Date2019-11-15
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Irras USA, Ltd.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192289. 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 Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Irras USA, Ltd.. The 510(k) number is K192289.

When did IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit receive FDA 510(k) clearance?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192289.

Who is the listed applicant for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

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

What is the FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

The FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is JXG.

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Other records listing Irras USA, Ltd. 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)K222471IRRAflow Active Fluid Exchange System (AFES)K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Related Devices (Code: JXG)

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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