AMICON DIAFILTER 40. HEMOFILTER— 510(k) K840449

Name: FDA 510(k) clearance K840449
Creator: U.S. Food and Drug Administration
Published: 1984-03-23

Substantially Equivalent

Medical Device Consultants, Inc.

FDA 510(k) clearance K840449 for AMICON DIAFILTER 40. HEMOFILTER, Substantially Equivalent on 1984-03-23. Applicant: Medical Device Consultants, Inc.. Device class: 2.

Clearance details

Applicant: Medical Device Consultants, Inc.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 1984-02-01
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, 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.