TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET— 510(k) K111351
Substantially EquivalentUs Infusion Dba Truecare Biomedix
FDA 510(k) clearance K111351 for TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET, Substantially Equivalent on 2011-09-29. Applicant: Us Infusion Dba Truecare Biomedix.
Clearance details
- Applicant
- Us Infusion Dba Truecare Biomedix
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Miami, FL, US
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.