Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit— 510(k) K213602

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K213602 for Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit, Substantially Equivalent on 2022-01-14. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: 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

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, 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.