Cleared Traditional

MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR

K140831 · Care Fusion · General Hospital
Apr 2014
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K140831 is an FDA 510(k) clearance for the MAXZERO EXTENSION SET WITH NEEDLESS 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 15, 2014, 13 days after receiving the submission on April 2, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K140831 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2014
Decision Date April 15, 2014
Days to Decision 13 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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