BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER— 510(k) K033350

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K033350 for BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER, Substantially Equivalent on 2003-11-18. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2003-10-20
Decision date: 2003-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin Lakes, NJ, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.