TS-180 SERIES TUBING SET— 510(k) K821138

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K821138 for TS-180 SERIES TUBING SET, Substantially Equivalent on 1982-05-10. Applicant: Extracorporeal Medical Specialities, Inc..

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1982-04-21
Decision date: 1982-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.