MEDISYSTEMS DIALYSIS PRIMING SETS— 510(k) K971860

Substantially Equivalent

Medisystems Corp.

FDA 510(k) clearance K971860 for MEDISYSTEMS DIALYSIS PRIMING SETS, Substantially Equivalent on 1997-08-18. Applicant: Medisystems Corp..

Clearance details

Applicant: Medisystems Corp.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-20
Decision date: 1997-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.