FDA 510(k) Applications for Medical Device Product Code "BSO"
(Catheter, Conduction, Anesthetic)

FDA 510(k) Number Applicant Device Name Decision Date
K895204 ABBOTT LABORATORIES EPI-CATH(TM) EPIDURAL CATHETER 11/15/1989
K000886 ABBOTT LABORATORIES SPIROL EPIDURAL CATHETER 10/05/2000
K050557 AMERICAN MEDICAL TECHNOLOGIES, INC. AMT NANOCATH 05/27/2005
K840202 ARIES MEDICAL, INC. EPIDURAL CATHETER 02/27/1984
K993592 AXIOM MEDICAL, INC. AXIOM MULTIPURPOSE WOUND DRAIN 05/17/2000
K971851 AXIOM MEDICAL, INC. INTERPLEURAL ANESTHESIA CATHETER 01/22/1998
K153297 B. BRAUN MEDICAL INC Perifix and Contiplex Catheter 08/12/2016
K171584 B. Braun Medical Inc. B. Braun Tear-Away Introducer Needle 12/22/2017
K042488 B. BRAUN MEDICAL, INC. PERIFIX CATHETER AND CONTIPLEX CATHETER 09/30/2004
K022019 B. BRAUN MEDICAL, INC. PERIFIX CATHETER CONNECTOR 08/01/2002
K090884 B. BRAUN MEDICAL, INC. PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. 06/29/2009
K102594 BAXANO, INC. IO-FLEX CATHETER 01/19/2011
K951092 BAXTER HEALTHCARE CORP. CATHETER SECUREMENT DEVICE 03/24/1995
K896712 BAXTER HEALTHCARE CORP. PHARMASEAL EPIDURAL CATHETER 06/18/1990
K897194 BAXTER HEALTHCARE CORP. PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL 06/18/1990
K924995 BOSTON PACIFIC MEDICAL, INC. 4 SURE TM ANESTHESIA EXTENSION SET 12/30/1992
K093920 BUSSE HOSPITAL DISPOSABLES BUSSE EPIDURAL CATHETER KIT 08/06/2010
K070465 BUSSE HOSPITAL DISPOSABLES, INC. BUSSE EPIDURAL CATHETER 07/19/2007
K854601 CONCORD LABORATORIES, INC. SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH 01/10/1986
K951927 CSEN LTD. COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER) 05/30/1997
K023233 EBI, L.P. EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM 12/13/2002
K032390 EBI, L.P. MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM 08/29/2003
K981329 EPIMED INTERNATIONAL, INC. FETH-R-KATH 08/26/1998
K133316 EPIMED INTERNATIONAL, INC. SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) 05/28/2014
K023140 EPIMED INTERNATIONAL, INC. VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 08/15/2003
K171193 Ferrosan Medical Devices SP. Z O.O. Certa Catheter 12/18/2017
K863792 GISH BIOMEDICAL, INC. DURACATH, GISH MODEL NO. DVAC-XXXX 12/05/1986
K161232 HALYARD HEALTH ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit 09/30/2016
K043456 I-FLOW CORP. MODIFICATION TO SOAKER CATHETER 01/11/2005
K051401 I-FLOW CORP. ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER 11/30/2005
K063234 I-FLOW CORP. ON-Q INTRODUCERS 11/21/2006
K173541 Imedicom Co., Ltd. EPINAUT 08/24/2018
K150789 IMEDICOM CO., LTD. SPINAUT-E, SPINAUT-I 03/01/2016
K930219 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE 04/27/1993
K922113 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH 12/03/1992
K143164 KIMBERLY-CLARK CORPORATION ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set 12/02/2014
K072050 LIFE-TECH, INC. PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS 10/18/2007
K884969 MEDEVICE, INC. BIO-MATE(TM) EPIDURAL CATHETER 06/23/1989
K901129 MEDEVICE, INC. BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER 03/30/1990
K954584 MEDIC EVALUATION DEVICES & INSTRUMENTS CORP. RACZ EPIDURAL CATHETER 10/08/1996
K930539 MEDICAL COMPONENTS, INC. MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY 08/27/1993
K150731 MEDLINE INDUSTRIES, INC. Medline Epidural Catheter 03/07/2016
K001717 MICOR, INC. MICOR CONDUCTION CATHETER 09/20/2000
K991879 MICOR, INC. SPRING-WOUND EPIDURAL CATHETER 10/28/1999
K822436 MOOREHEAD HOSPITAL PRODUCTS, INC. DNA MEDICAL DURACATH 10/22/1982
K172777 PAJUNK GmbH Medizintechnologie Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 05/03/2018
K152952 PAJUNK GmbH Medizintechnologie E-Cath 07/13/2016
K080675 PAJUNK GMBH MEDIZINTECHNOLOGIE PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT 06/20/2008
K832352 PARKE-DAVIS CO. 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE 01/13/1984
K850439 PARKE-DAVIS CO. DESERET EPIDURAL CATHETER 03/05/1985
K850505 PARKE-DAVIS CO. DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER 03/11/1985
K111031 PLAN 1 HEALTH, S.R.L. PAINFUSOR CATHETER 07/08/2011
K802065 PORTEX, INC. CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG 09/09/1980
K823702 RSP, INC. EPIDURAL CATHETER 01/07/1983
K992471 SIMS PORTEX, INC. SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 10/22/1999
K935927 SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. CONCORD/PORTEX EPIDURAL CATHETERS 09/09/1994
K051524 SMITHS MEDICAL ASD, INC. LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 07/07/2005
K062005 SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CATHETER 10/18/2006
K081404 SPINAL INTEGRATION LLC SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT 10/21/2008
K072702 STRYKER INSTRUMENTS, INSTRUMENTS DIV. STRYKER ANTIMIC CATHETER 03/19/2008
K102460 SUMMIT MEDICAL PRODUCTS, INC AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH 01/13/2011
K110814 SUMMIT MEDICAL PRODUCTS, INC AMBIT TUNNELER 04/08/2011
K991259 TE ME NA S.A.R.L. TE ME NA EPIDURAL CATHETER 02/21/2001
K162522 TELEFLEX MEDICAL , INC. UltraCath Continuous Nerve block Catheter 03/17/2017
K140110 TELEFLEX, INC. FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET 03/27/2015
K832232 TERUMO MEDICAL CORP. EPINEED EPIDURAL CATHETER 08/08/1983
K850009 VAS-CATH OF CANADA LTD. EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER 05/13/1985
K122661 VITAL 5 VITAL 5 RELEAF CATHETER 02/27/2013


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