0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe— 510(k) K161552
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K161552 for 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe, Substantially Equivalent on 2017-02-02. Applicant: Becton, Dickinson and Company.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code NGT
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Franklin Lakes, NJ, US
Adverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
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.