ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32— 510(k) K080470
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K080470 for ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32, Substantially Equivalent on 2008-09-12. Applicant: Maquet Cardiopulmonary, AG.
Clearance details
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Code KFM
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hirrlingen, DE
Adverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
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.