SARNS 9000 WITH CENTRIFUGAL PUMP OPTION— 510(k) K884659
Substantially Equivalent3M Health Care, Sarns
FDA 510(k) clearance K884659 for SARNS 9000 WITH CENTRIFUGAL PUMP OPTION, Substantially Equivalent on 1989-01-24. Applicant: 3M Health Care, Sarns.
Clearance details
- Applicant
- 3M Health Care, Sarns
- Product code
- Code KFM
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
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.