K882498

Substantially Equivalent

EXTENDED LIFE CAPD TRANSFER SET 5C4444

Applicant: Baxter Healthcare Corp
Product code: KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1988-06-17
Decision date: 1988-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

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.