CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS— 510(k) K883239

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K883239 for CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS, Substantially Equivalent on 1988-10-21. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1988-08-01
Decision date: 1988-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, 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.