Cleared Traditional

IV Administration

K142622 · Hospira, Inc. · General Hospital
Jan 2015
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K142622 is an FDA 510(k) clearance for the IV Administration, 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 15, 2015, 121 days after receiving the submission on September 16, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K142622 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2014
Decision Date January 15, 2015
Days to Decision 121 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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