510(k) K896006— DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095

Substantially Equivalent

Baxter Healthcare Corp

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-13
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

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.