IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit— 510(k) K200807

Name: FDA 510(k) clearance K200807
Creator: U.S. Food and Drug Administration
Published: 2020-04-29

Substantially Equivalent

Irras USA, Inc.

FDA 510(k) clearance K200807 for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit, Substantially Equivalent on 2020-04-29. Applicant: Irras USA, Inc.. Device class: 2.

Clearance details

Applicant: Irras USA, Inc.
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2020-03-27
Decision date: 2020-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.