BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM— 510(k) K111366
Substantially EquivalentBecton, Dickinson and Company (BD)
FDA 510(k) clearance K111366 for BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM, Substantially Equivalent on 2011-09-30. Applicant: Becton, Dickinson and Company (BD).
Clearance details
- Applicant
- Becton, Dickinson and Company (BD)
- Product code
- Code FOZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy, UT, US
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.