EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170— 510(k) K030974

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K030974 for EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170, Substantially Equivalent on 2003-04-25. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2003-03-28
Decision date: 2003-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgaw Park, IL, US

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Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.