PERITONEAL CATHETERS WITH AN ADDED FUNCTION— 510(k) K890288

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K890288 for PERITONEAL CATHETERS WITH AN ADDED FUNCTION, Substantially Equivalent on 1989-03-27. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1989-01-19
Decision date: 1989-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, 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.