DeviceClearance

K200807

Substantially Equivalent

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Applicant
Irras USA, Inc.
Product code
JXG
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDF View on FDA.gov ↗

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.