Cleared Traditional

Microvolume Luer Access Device

K212842 · B.Braun Medical, Inc. · General Hospital
Jan 2022
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K212842 is an FDA 510(k) clearance for the Microvolume Luer Access Device, 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 January 18, 2022, 133 days after receiving the submission on September 7, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K212842 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2021
Decision Date January 18, 2022
Days to Decision 133 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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