Cleared Traditional

Carefusion NeutraClear Needle-free connector (EL-NC1000)

K171117 · Cair Lgl · General Hospital
Sep 2017
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K171117 is an FDA 510(k) clearance for the Carefusion NeutraClear Needle-free connector (EL-NC1000), a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on September 1, 2017, 140 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 K171117 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2017
Decision Date September 01, 2017
Days to Decision 140 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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