510(k) K070286— BIO-CONSOLE, MODEL 560

Substantially Equivalent

Medtronic

Clearance details

Applicant: Medtronic
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 2007-01-29
Decision date: 2007-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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.