DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR— 510(k) K992599

Substantially Equivalent

Dideco S.P.A.

FDA 510(k) clearance K992599 for DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR, Substantially Equivalent on 1999-11-01. Applicant: Dideco S.P.A..

Clearance details

Applicant: Dideco S.P.A.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1999-08-03
Decision date: 1999-11-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Attleboro, MA, 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.