COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS— 510(k) K964043

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K964043 for COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS, Substantially Equivalent on 1997-09-29. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1996-10-09
Decision date: 1997-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
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.