DeviceClearance

K830257

Substantially Equivalent

NON-STERILE PERITONEAL ACCESS CATHET-

Applicant
Evermed, Inc.
Product code
FKX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FKX

product code FKX
Death
501
Injury
6,720
Malfunction
18,508
Other
1
Total
25,730

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.