510(k) K941921— BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550

Substantially Equivalent

Medtronic Bio-Medicus, Inc.

Clearance details

Applicant: Medtronic Bio-Medicus, Inc.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 1994-04-20
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, 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.