BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR— 510(k) K140591

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K140591 for BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR, Substantially Equivalent on 2014-05-14. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2014-03-07
Decision date: 2014-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin Lakes, NJ, US

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Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.