BD Alaris Pump Epidural Infusion Set— 510(k) K221319
Substantially EquivalentCare Fusion
FDA 510(k) clearance K221319 for BD Alaris Pump Epidural Infusion Set, Substantially Equivalent on 2023-07-21. Applicant: Care Fusion.
Clearance details
- Applicant
- Care Fusion
- Product code
- Code PWH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code PWH
product code PWH- Other
- 1
- Total
- 1
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.