K213602

Substantially Equivalent

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

Applicant: Covidien, LLC
Product code: FJS
Advisory panel: Gastroenterology, Urology
Date received: 2021-11-15
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.