COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700— 510(k) K030462

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K030462 for COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700, Substantially Equivalent on 2003-03-06. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2003-02-12
Decision date: 2003-03-06
Decision: Substantially Equivalent
Clearance type: Special
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.