IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS— 510(k) K991908

Name: FDA 510(k) clearance K991908
Creator: U.S. Food and Drug Administration
Published: 2000-04-17

Substantially Equivalent

Idemsa

FDA 510(k) clearance K991908 for IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS, Substantially Equivalent on 2000-04-17. Applicant: Idemsa. Device class: 2.

Clearance details

Applicant: Idemsa
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1999-06-07
Decision date: 2000-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, US

Download summary PDF View on FDA.gov ↗

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K010366 — DISPOSABLE STORAGE CAP2001-11-28
K011148 — ULTRACONCENTRATOR SYSTEM2001-06-13

Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.