BLOOD HAND PUMP ADMINISTRATION SET— 510(k) K050115
Substantially EquivalentCardinal Health, Alaris Products
FDA 510(k) clearance K050115 for BLOOD HAND PUMP ADMINISTRATION SET, Substantially Equivalent on 2005-04-01. Applicant: Cardinal Health, Alaris Products.
Clearance details
- Applicant
- Cardinal Health, Alaris Products
- Product code
- Code BRZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code BRZ
product code BRZ- Malfunction
- 458
- Total
- 458
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.