Cleared Traditional

IV Sets not made with PVC

K191658 · B.Braun Medical, Inc. · General Hospital
Mar 2020
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K191658 is an FDA 510(k) clearance for the IV Sets not made with PVC, 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 19, 2020, 272 days after receiving the submission on June 21, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K191658 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2019
Decision Date March 19, 2020
Days to Decision 272 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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