MEDISYSTEMS PERITONEAL DIALYSIS SETS— 510(k) K963668

Substantially Equivalent

Medisystems Corp.

FDA 510(k) clearance K963668 for MEDISYSTEMS PERITONEAL DIALYSIS SETS, Substantially Equivalent on 1997-08-15. Applicant: Medisystems Corp..

Clearance details

Applicant: Medisystems Corp.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1996-09-13
Decision date: 1997-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.