BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System— 510(k) K200891
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K200891 for BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System, Substantially Equivalent on 2021-06-02. Applicant: Becton, Dickinson and Company.
Clearance details
- Applicant
- Becton, Dickinson and Company
- 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.