Q-FLO CLOSED MALE LUER CONNECTOR— 510(k) K121554
Substantially EquivalentUs Fusion, LLC. Dba Truecare Biomedix-USA
FDA 510(k) clearance K121554 for Q-FLO CLOSED MALE LUER CONNECTOR, Substantially Equivalent on 2012-06-08. Applicant: Us Fusion, LLC. Dba Truecare Biomedix-USA.
Clearance details
- Applicant
- Us Fusion, LLC. Dba Truecare Biomedix-USA
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South 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.