Cleared Special

INFUSION SETS

K103344 · Hospira, Inc. · General Hospital
Dec 2010
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K103344 is an FDA 510(k) clearance for the INFUSION 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 December 10, 2010, 25 days after receiving the submission on November 15, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K103344 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2010
Decision Date December 10, 2010
Days to Decision 25 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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