COBE CENTURY PERFUSION PUMP— 510(k) K960974

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K960974 for COBE CENTURY PERFUSION PUMP, Substantially Equivalent on 1997-07-14. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DWB
Advisory panel: Cardiovascular
Date received: 1996-03-11
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

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Adverse events under product code DWB

product code DWB

Death: 2
Total: 2

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.