D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR— 510(k) K043323

Substantially Equivalent

Dideco S.R.L.

FDA 510(k) clearance K043323 for D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR, Substantially Equivalent on 2005-02-01. Applicant: Dideco S.R.L..

Clearance details

Applicant: Dideco S.R.L.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2004-12-02
Decision date: 2005-02-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Waltham, MA, US

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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.