MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS— 510(k) K855251

Substantially Equivalent

Advocacy International, Ltd.

FDA 510(k) clearance K855251 for MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS, Substantially Equivalent on 1986-02-04. Applicant: Advocacy International, Ltd..

Clearance details

Applicant: Advocacy International, Ltd.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1985-12-30
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.