FDA 510(k) Applications for Medical Device Product Code "BSO"
(Catheter, Conduction, Anesthetic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K000886 | ABBOTT LABORATORIES | SPIROL EPIDURAL CATHETER | 10/05/2000 |
| K050557 | AMERICAN MEDICAL TECHNOLOGIES, INC. | AMT NANOCATH | 05/27/2005 |
| 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 |
| K231242 | B. Braun Medical Inc. | Perifix FX Catheter; Contiplex FX Catheter | 09/15/2023 |
| 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 |
| K093920 | BUSSE HOSPITAL DISPOSABLES | BUSSE EPIDURAL CATHETER KIT | 08/06/2010 |
| K070465 | BUSSE HOSPITAL DISPOSABLES, INC. | BUSSE EPIDURAL CATHETER | 07/19/2007 |
| K191470 | Cimpax ApS | C-CAT Anaesthesia Catheter kit | 10/25/2019 |
| 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 |
| K200624 | Epimed International Inc. | Percutaneous Introducer | 04/27/2020 |
| 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 |
| K161232 | HALYARD HEALTH | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | 09/30/2016 |
| K193664 | HK Surgical | SubQKath Catheter and Needle Set | 09/09/2020 |
| 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 |
| 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 |
| K954584 | MEDIC EVALUATION DEVICES & INSTRUMENTS CORP. | RACZ EPIDURAL CATHETER | 10/08/1996 |
| K150731 | MEDLINE INDUSTRIES, INC. | Medline Epidural Catheter | 03/07/2016 |
| K181782 | Medline Industries, Inc. | Medline Reinforced Epidural Catheter | 03/04/2019 |
| K001717 | MICOR, INC. | MICOR CONDUCTION CATHETER | 09/20/2000 |
| K991879 | MICOR, INC. | SPRING-WOUND EPIDURAL CATHETER | 10/28/1999 |
| 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 |
| K111031 | PLAN 1 HEALTH, S.R.L. | PAINFUSOR CATHETER | 07/08/2011 |
| K992471 | SIMS PORTEX, INC. | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | 10/22/1999 |
| 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 |
| K230603 | Teleflex Medical | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adap | 08/30/2023 |
| 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 |
| K122661 | VITAL 5 | VITAL 5 RELEAF CATHETER | 02/27/2013 |
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