DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR— 510(k) K010478

Substantially Equivalent

Dideco

FDA 510(k) clearance K010478 for DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR, Substantially Equivalent on 2001-09-27. Applicant: Dideco.

Clearance details

Applicant: Dideco
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2001-02-20
Decision date: 2001-09-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arvada, CO, 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.