CAPD DISPOSABLE Y SYSTEM - DY SET— 510(k) K883393

Substantially Equivalent

Medionics International , Ltd.

FDA 510(k) clearance K883393 for CAPD DISPOSABLE Y SYSTEM - DY SET, Substantially Equivalent on 1988-11-03. Applicant: Medionics International , Ltd..

Clearance details

Applicant: Medionics International , Ltd.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1988-08-09
Decision date: 1988-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.