BIO-CONSOLE, MODEL 560— 510(k) K051303

Substantially Equivalent

Medtronic Perfusion Systems

FDA 510(k) clearance K051303 for BIO-CONSOLE, MODEL 560, Substantially Equivalent on 2005-06-10. Applicant: Medtronic Perfusion Systems.

Clearance details

Applicant: Medtronic Perfusion Systems
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 2005-05-19
Decision date: 2005-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Brooklyn Park, MN, US

Download summary PDF View on FDA.gov ↗

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.