VAS-CATH PERITONEAL DIALYSIS CATHETER— 510(k) K871817

Substantially Equivalent

Vas-Cath of Canada , Ltd.

FDA 510(k) clearance K871817 for VAS-CATH PERITONEAL DIALYSIS CATHETER, Substantially Equivalent on 1987-07-16. Applicant: Vas-Cath of Canada , Ltd..

Clearance details

Applicant: Vas-Cath of Canada , Ltd.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1987-05-11
Decision date: 1987-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L5a 3v3, CA

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.