FRESENIUS HEMOFLOW F80 DIALYZER— 510(k) K861106

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K861106 for FRESENIUS HEMOFLOW F80 DIALYZER, Substantially Equivalent on 1986-04-07. Applicant: Seratronics, Inc..

Clearance details

Applicant: Seratronics, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1986-03-24
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, 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.