QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030— 510(k) K030264

Substantially Equivalent

Jostra AG

FDA 510(k) clearance K030264 for QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030, Substantially Equivalent on 2003-02-26. Applicant: Jostra AG.

Clearance details

Applicant: Jostra AG
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2003-01-27
Decision date: 2003-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Hirrlingen, DE

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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.