COBE REVOLUTION— 510(k) K011835

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K011835 for COBE REVOLUTION, Substantially Equivalent on 2002-02-12. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2001-06-12
Decision date: 2002-02-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arvada, CO, US

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Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.