COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR— 510(k) K013480

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K013480 for COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR, Substantially Equivalent on 2001-11-16. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2001-10-19
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Special
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.