BD Centro Vena Acute Central Line (7 French Dual Lumen)— 510(k) K200266
Substantially EquivalentBard Access Systems, Inc. (Bard Has Joined Bd)
FDA 510(k) clearance K200266 for BD Centro Vena Acute Central Line (7 French Dual Lumen), Substantially Equivalent on 2020-04-07. Applicant: Bard Access Systems, Inc. (Bard Has Joined Bd).
Clearance details
- Applicant
- Bard Access Systems, Inc. (Bard Has Joined Bd)
- Product code
- Code FOZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake Ciy,, 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.