IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit— 510(k) K192289
Substantially EquivalentIrras USA, Ltd.
FDA 510(k) clearance K192289 for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit, Substantially Equivalent on 2019-11-15. Applicant: Irras USA, Ltd..
Clearance details
- Applicant
- Irras USA, Ltd.
- Product code
- Code JXG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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, through . 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.