ClearanceBrief
Panels › Anesthesiology › Product code BSO · Class 2

Catheter, Conduction, Anesthetic

Regulation 868.5120

0510(k)s in 12 months (75 all time)
2recalls in 12 months (119 all time)
21recalls that name a 510(k)
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Top companies in BSO

Company510(k)sRecalls
B.Braun Medical, Inc.693
ARROW INTERNATIONAL, LLC018
Epimed International, Inc.45
I-Flow Corp.32
Baxter Healthcare Corp30
PAJUNK GmbH Medizintechnologie30
Parke-Davis Co.30
Smiths Medical Asd, Inc.21
Abbott Laboratories20
Axiom Medical, Inc.20
Decided510(k)Device and applicantCode
Feb 13, 2025K241410EDEN ControlCath
Jmt Co., Ltd., KR
BSO
Sep 15, 2023K231242Perifix FX Catheter; Contiplex FX Catheter
B.Braun Medical, Inc.
BSO
Aug 30, 2023K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection)
Teleflex Medical
BSO
Sep 9, 2020K193664SubQKath Catheter and Needle Set
Hk Surgical
BSO
Apr 27, 2020K200624Percutaneous Introducer
Epimed International, Inc.
BSO
Oct 25, 2019K191470C-CAT Anaesthesia Catheter kit
Cimpax Aps, DK
BSO
Mar 4, 2019K181782Medline Reinforced Epidural Catheter
Medline Industries, Inc.
BSO
Aug 24, 2018K173541EPINAUT
Imedicom Co., Ltd., KR
BSO
May 3, 2018K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
PAJUNK GmbH Medizintechnologie, DE
BSO
Dec 22, 2017K171584B. Braun Tear-Away Introducer Needle
B.Braun Medical, Inc.
BSO
Dec 18, 2017K171193Certa Catheter
Ferrosan Medical Devices Sp. Z.O.O., PL
BSO
Mar 17, 2017K162522UltraCath Continuous Nerve block Catheter
Teleflexmedical, Inc.
BSO
Sep 30, 2016K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
Halyard Health
BSO
Aug 12, 2016K153297Perifix and Contiplex Catheter
B.Braun Medical, Inc.
BSO
Jul 13, 2016K152952E-Cath
PAJUNK GmbH Medizintechnologie, DE
BSO
Mar 7, 2016K150731Medline Epidural Catheter
Medline Industries, Inc.
BSO
Mar 1, 2016K150789SPINAUT-E, SPINAUT-I
Imedicom Co., Ltd., KR
BSO
Mar 27, 2015K140110FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
Teleflex, Inc.
BSO
Dec 2, 2014K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
Kimberly-Clark Corporation
BSO
May 28, 2014K133316SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
Epimed International, Inc.
BSO
Feb 27, 2013K122661VITAL 5 RELEAF CATHETER
Vital 5
BSO
Jul 8, 2011K111031PAINFUSOR CATHETER
Plan 1 Health, S.R.L.
BSO
Apr 8, 2011K110814AMBIT TUNNELER
Summit Medical Products, Inc.
BSO
Jan 19, 2011K102594IO-FLEX CATHETER
Baxano, Inc.
BSO
Jan 13, 2011K102460AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
Summit Medical Products, Inc.
BSO
Aug 6, 2010K093920BUSSE EPIDURAL CATHETER KIT
Busse Hospital Disposables
BSO
Jun 29, 2009K090884PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
B.Braun Medical, Inc.
BSO
Oct 21, 2008K081404SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
Spinal Integration, LLC
BSO
Jun 20, 2008K080675PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
PAJUNK GmbH Medizintechnologie, DE
BSO
Mar 19, 2008K072702STRYKER ANTIMIC CATHETER
Stryker Instruments, Instruments Div.
BSO
Oct 18, 2007K072050PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
Life-Tech, Inc.
BSO
Jul 19, 2007K070465BUSSE EPIDURAL CATHETER
Busse Hospital Disposables, Inc.
BSO
Nov 21, 2006K063234ON-Q INTRODUCERS
I-Flow Corp.
BSO
Oct 18, 2006K062005PORTEX EPIDURAL CATHETER
Smiths Medical Asd, Inc.
BSO
Nov 30, 2005K051401ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
I-Flow Corp.
BSO
Jul 7, 2005K051524LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
Smiths Medical Asd, Inc.
BSO
May 27, 2005K050557AMT NANOCATH
American Medical Technologies, Inc.
BSO
Jan 11, 2005K043456MODIFICATION TO SOAKER CATHETER
I-Flow Corp.
BSO
Sep 30, 2004K042488PERIFIX CATHETER AND CONTIPLEX CATHETER
B.Braun Medical, Inc.
BSO
Aug 29, 2003K032390MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
Ebi, L.P.
BSO
Aug 15, 2003K023140VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
Epimed International, Inc.
BSO
Dec 13, 2002K023233EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
Ebi, L.P.
BSO
Aug 1, 2002K022019PERIFIX CATHETER CONNECTOR
B.Braun Medical, Inc.
BSO
Feb 21, 2001K991259TE ME NA EPIDURAL CATHETER
Te ME NA S.A.R.L.
BSO
Oct 5, 2000K000886SPIROL EPIDURAL CATHETER
Abbott Laboratories
BSO
Sep 20, 2000K001717MICOR CONDUCTION CATHETER
Micor, Inc.
BSO
May 17, 2000K993592AXIOM MULTIPURPOSE WOUND DRAIN
Axiom Medical, Inc.
BSO
Oct 28, 1999K991879SPRING-WOUND EPIDURAL CATHETER
Micor, Inc.
BSO
Oct 22, 1999K992471SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
Sims Portex, Inc.
BSO
Aug 26, 1998K981329FETH-R-KATH
Epimed International, Inc.
BSO

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