FRESENIUS ULTRAFLUX AV400, AV600— 510(k) K864587

Name: FDA 510(k) clearance K864587
Creator: U.S. Food and Drug Administration
Published: 1987-03-03

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K864587 for FRESENIUS ULTRAFLUX AV400, AV600, Substantially Equivalent on 1987-03-03. Applicant: Seratronics, Inc.. Device class: 2.

Clearance details

Applicant: Seratronics, Inc.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 1986-11-21
Decision date: 1987-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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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.