Cleared Traditional

IV Administration Sets

K202618 · B.Braun Medical, Inc. · General Hospital
Sep 2021
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K202618 is an FDA 510(k) clearance for the IV Administration Sets, 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 September 24, 2021, 379 days after receiving the submission on September 10, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K202618 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2020
Decision Date September 24, 2021
Days to Decision 379 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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