Cleared Traditional

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)

K171118 · Cair Lgl · General Hospital
Aug 2017
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K171118 is an FDA 510(k) clearance for the Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s), a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on August 15, 2017, 123 days after receiving the submission on April 14, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K171118 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2017
Decision Date August 15, 2017
Days to Decision 123 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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