Cleared Traditional

Hospira Primary Sets

K142367 · Hospira, Inc. · General Hospital
Nov 2014
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K142367 is an FDA 510(k) clearance for the Hospira Primary Sets, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on November 25, 2014, 92 days after receiving the submission on August 25, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K142367 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2014
Decision Date November 25, 2014
Days to Decision 92 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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