BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE— 510(k) K123213

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K123213 for BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE, Substantially Equivalent on 2013-01-09. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant
Becton, Dickinson & CO
Product code
Code ONB
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lakes, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ONB

product code ONB
Malfunction
3,615
Other
13
Total
3,628

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.