ACR 2500 CARDIOTOMY RESERVOIR FILTER— 510(k) K842391

Substantially Equivalent

Electromedics, Inc.

FDA 510(k) clearance K842391 for ACR 2500 CARDIOTOMY RESERVOIR FILTER, Substantially Equivalent on 1985-05-21. Applicant: Electromedics, Inc..

Clearance details

Applicant: Electromedics, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1984-06-18
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.