Cleared Traditional

IV Administration Set

K173361 · B.Braun Medical, Inc. · General Hospital
Jun 2018
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K173361 is an FDA 510(k) clearance for the IV Administration Set, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on June 26, 2018, 243 days after receiving the submission on October 26, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K173361 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2017
Decision Date June 26, 2018
Days to Decision 243 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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