K233021

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device

510(k) number
K233021
Device name
BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device
Applicant
Care Fusion CA · US
Product code
LHI — Set, I.V. Fluid Transfer
Decision date
2024-03-06
Date received
2023-09-22
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K233021.pdf

Official FDA record: K233021
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.