Cleared Special

Carefusion NeutraClear Needle-free connector

K171132 · Cair Lgl · General Hospital
Jul 2017
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K171132 is an FDA 510(k) clearance for the Carefusion NeutraClear Needle-free connector, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on July 31, 2017, 105 days after receiving the submission on April 17, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K171132 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2017
Decision Date July 31, 2017
Days to Decision 105 days
Submission Type Special
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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