Cleared Traditional

LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526

K063239 · Hospira, Inc. · General Hospital
Dec 2006
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K063239 is an FDA 510(k) clearance for the LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526, a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 11, 2006, 46 days after receiving the submission on October 26, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K063239 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2006
Decision Date December 11, 2006
Days to Decision 46 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPK — Tubing, Fluid Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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