Cleared Traditional

Hospira Blood Set

K143087 · Hospira, Inc. · General Hospital
Mar 2015
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K143087 is an FDA 510(k) clearance for the Hospira Blood 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 March 4, 2015, 128 days after receiving the submission on October 27, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K143087 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2014
Decision Date March 04, 2015
Days to Decision 128 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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