BD Intima II PLUS Closed IV Catheter System— 510(k) K172204
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K172204 for BD Intima II PLUS Closed IV Catheter System, Substantially Equivalent on 2017-08-17. 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.