PENTATRASFU BLOOD TRANSFUSION SETS— 510(k) K041496
Substantially EquivalentPentaferte S.P.A
FDA 510(k) clearance K041496 for PENTATRASFU BLOOD TRANSFUSION SETS, Substantially Equivalent on 2005-06-30. Applicant: Pentaferte S.P.A.
Clearance details
- Applicant
- Pentaferte S.P.A
- Product code
- Code BRZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Parkland, FL, 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.