Cleared Traditional

BD SmartSite? Needle-Free Connector

K223088 · Care Fusion · General Hospital
Apr 2023
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K223088 is an FDA 510(k) clearance for the BD SmartSite? Needle-Free Connector, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on April 7, 2023, 189 days after receiving the submission on September 30, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K223088 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date April 07, 2023
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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