ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012— 510(k) K102109

Substantially Equivalent

Eurosets S.R.L

FDA 510(k) clearance K102109 for ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012, Substantially Equivalent on 2011-02-15. Applicant: Eurosets S.R.L.

Clearance details

Applicant: Eurosets S.R.L
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2010-07-28
Decision date: 2011-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medolla, Modena, IT

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.