DeviceClearance

K180485

Unknown

Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

Applicant
Covidien, LLC
Product code
FJS
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Mansfield, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS
Death
34
Injury
652
Malfunction
576
Other
6
Total
1,268

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.