Cleared Special

NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS

K132734 · Baxter Healthcare Corp · General Hospital
Oct 2013
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K132734 is an FDA 510(k) clearance for the NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on October 8, 2013, 35 days after receiving the submission on September 3, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K132734 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2013
Decision Date October 08, 2013
Days to Decision 35 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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