BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems— 510(k) K161777
Substantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.
FDA 510(k) clearance K161777 for BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems, Substantially Equivalent on 2016-08-29. Applicant: Becton Dickinson Infusion Therapy Systems, Inc..
Clearance details
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- 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.