BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE— 510(k) K131964

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K131964 for BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE, Substantially Equivalent on 2013-07-24. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 2013-06-27
Decision date: 2013-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

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Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.