Cleared Traditional

IV Administration Set

K213778 · B.Braun Medical, Inc. · General Hospital
Mar 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K213778 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 March 3, 2022, 90 days after receiving the submission on December 3, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K213778 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2021
Decision Date March 03, 2022
Days to Decision 90 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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