510(k) K800178— EXTRACORP.'S INTERSEPT CUS. TUBING PK.

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 1980-01-28
Decision date: 1980-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.