DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET— 510(k) K920586

Substantially Equivalent

National Medical Care, Medical Products Div., Inc.

FDA 510(k) clearance K920586 for DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET, Substantially Equivalent on 1992-09-21. Applicant: National Medical Care, Medical Products Div., Inc..

Clearance details

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-10
Decision date: 1992-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, 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.