MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER— 510(k) K936091
Substantially EquivalentMedtronic Bio-Medicus, Inc.
FDA 510(k) clearance K936091 for MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER, Substantially Equivalent on 1994-12-23. Applicant: Medtronic Bio-Medicus, Inc..
Clearance details
- Applicant
- Medtronic Bio-Medicus, Inc.
- Product code
- Code DWA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, through . 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.