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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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