Cleared Traditional

Hospira Extension Set

K142433 · Hospira, Inc. · General Hospital
Dec 2014
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K142433 is an FDA 510(k) clearance for the Hospira Extension Set, 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 8, 2014, 101 days after receiving the submission on August 29, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K142433 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2014
Decision Date December 08, 2014
Days to Decision 101 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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