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

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..

Clearance details

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

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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.