FDA 510(k) Applications Submitted by B. BRAUN MEDICAL INC.

FDA 510(k) Number Submission Date Device Name Applicant
K143082 10/27/2014 IV Administration Sets with 200(micro)m Blood Filter B. Braun Medical Inc.
K170897 03/27/2017 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site B. Braun Medical Inc.
K201469 06/03/2020 Mini Spike Plus 6/8R B. Braun Medical Inc.
K191658 06/21/2019 IV Sets not made with PVC B. Braun Medical Inc.
K180801 03/28/2018 Actreen Hi-Lite Cath, Actreen Hi-Lite Set B. Braun Medical Inc.
K192577 09/19/2019 Actreen Hi-Lite Intermittent Urinary Catheters B. Braun Medical Inc.
K142596 09/15/2014 Infusomat Space Volumetric Infusion Pump B. Braun Medical Inc.
K153293 11/13/2015 Extension Set B. BRAUN MEDICAL INC.
K171584 05/31/2017 B. Braun Tear-Away Introducer Needle B. Braun Medical Inc.
K212842 09/07/2021 Microvolume Luer Access Device B. Braun Medical Inc.
K202618 09/10/2020 IV Administration Sets B. Braun Medical Inc.
K173803 12/15/2017 Omnican fine B. Braun Medical Inc.
K170595 02/28/2017 IV Administration Sets B. Braun Medical Inc.
K161623 06/13/2016 Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL B. Braun Medical Inc.
K223479 11/18/2022 AQUAbase nX B. Braun Medical Inc.
K151772 06/30/2015 Actreen Mini Intermittent Urinary Catheters B. BRAUN MEDICAL INC.
K231242 05/01/2023 Perifix FX Catheter; Contiplex FX Catheter B. Braun Medical Inc.
K192676 09/26/2019 Introcan Safety 2 IV Catheter 18-24 gauge B. Braun Medical Inc.
K182870 10/12/2018 Introcan Safety 3 Closed IV Catheter B. Braun Medical Inc.
K193101 11/08/2019 Omnifix Low Dead Space Luer Lock Syringe B. Braun Medical Inc.
K213664 11/22/2021 B. Braun Introcan Safety 2 IV Catheter B. Braun Medical Inc.
K150787 03/25/2015 Universal Spike B. Braun Medical Inc.
K151423 05/28/2015 APEX Compounding System Transfer Set B. BRAUN MEDICAL INC.
K173531 11/15/2017 Lockbox for Perfusor Space PCA Infusion Pump B. Braun Medical Inc.


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