Cleared Traditional

MaxZero Administration Sets

K143234 · Care Fusion · General Hospital
Nov 2014
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K143234 is an FDA 510(k) clearance for the MaxZero Administration Sets, 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 November 20, 2014, 10 days after receiving the submission on November 10, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K143234 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2014
Decision Date November 20, 2014
Days to Decision 10 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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