EXTRACORPOREALS' ALTERNATE MEMBRANE— 510(k) K801344

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K801344 for EXTRACORPOREALS' ALTERNATE MEMBRANE, Substantially Equivalent on 1980-07-21. Applicant: Extracorporeal Medical Specialities, Inc..

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1980-06-05
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.