Cleared Special

HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING

K103224 · Hospira, Inc. · General Hospital
Jan 2011
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K103224 is an FDA 510(k) clearance for the HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING, 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 7, 2011, 67 days after receiving the submission on November 1, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K103224 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2010
Decision Date January 07, 2011
Days to Decision 67 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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