SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR— 510(k) K031223

Substantially Equivalent

Dideco S.P.A.

FDA 510(k) clearance K031223 for SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR, Substantially Equivalent on 2003-05-02. Applicant: Dideco S.P.A..

Clearance details

Applicant: Dideco S.P.A.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2003-04-18
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.