Cleared Traditional

Hospira Extension Set, Hospira Primary Set

K161036 · Hospira, Inc. · General Hospital
Jan 2017
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K161036 is an FDA 510(k) clearance for the Hospira Extension Set, Hospira Primary Set, 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 January 6, 2017, 268 days after receiving the submission on April 13, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K161036 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2016
Decision Date January 06, 2017
Days to Decision 268 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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