Cleared Traditional

MaxZero Extension Sets with Needless Connector

K171957 · Carefusion 303, Inc. · General Hospital
Jul 2017
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K171957 is an FDA 510(k) clearance for the MaxZero Extension Sets with Needless Connector, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on July 19, 2017, 20 days after receiving the submission on June 29, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K171957 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2017
Decision Date July 19, 2017
Days to Decision 20 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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