Cleared Special

Hospira Administration Sets

K160870 · Hospira, Inc. · General Hospital
Jun 2016
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K160870 is an FDA 510(k) clearance for the Hospira Administration 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 June 1, 2016, 63 days after receiving the submission on March 30, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K160870 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2016
Decision Date June 01, 2016
Days to Decision 63 days
Submission Type Special
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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