Catheter, Conduction, Anesthetic

FDA product code BSO · Class II (moderate risk) · 21 CFR 868.5120 · Anesthesiology

75510(k) clearances
0PMA approvals
119recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K241410EDEN ControlCathBSO · Traditional Jmt Co., Ltd.02/13/2025SE
K231242Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional B.Braun Medical, Inc.09/15/2023SE
K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional Teleflex Medical08/30/2023SE
K193664SubQKath Catheter and Needle SetBSO · Traditional Hk Surgical09/09/2020SE
K200624Percutaneous IntroducerBSO · Traditional Epimed International, Inc.04/27/2020SE
K191470C-CAT Anaesthesia Catheter kitBSO · Traditional Cimpax Aps10/25/2019SE
K181782Medline Reinforced Epidural CatheterBSO · Traditional Medline Industries, Inc.03/04/2019SE
K173541EpinautBSO · Traditional Imedicom Co., Ltd.08/24/2018SE
K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional PAJUNK GmbH Medizintechnologie05/03/2018SE
K171584B. Braun Tear-Away Introducer NeedleBSO · Traditional B.Braun Medical, Inc.12/22/2017SE
K171193Certa CatheterBSO · Traditional Ferrosan Medical Devices Sp. Z.O.O.12/18/2017SE
K162522UltraCath Continuous Nerve block CatheterBSO · Traditional Teleflexmedical, Inc.03/17/2017SE
K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitBSO · Traditional Halyard Health09/30/2016SE
K153297Perifix and Contiplex CatheterBSO · Traditional B.Braun Medical, Inc.08/12/2016SE
K152952E-CathBSO · Traditional PAJUNK GmbH Medizintechnologie07/13/2016SE
K150731Medline Epidural CatheterBSO · Traditional Medline Industries, Inc.03/07/2016SE
K150789Spinaut-E, Spinaut-IBSO · Traditional Imedicom Co., Ltd.03/01/2016SE
K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetBSO · Traditional Teleflex, Inc.03/27/2015SE
K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetBSO · Special Kimberly-Clark Corporation12/02/2014SE
K133316Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End…BSO · Traditional Epimed International, Inc.05/28/2014SE
K122661Vital 5 Releaf CatheterBSO · Traditional Vital 502/27/2013SE
K111031Painfusor CatheterBSO · Traditional Plan 1 Health, S.R.L.07/08/2011SE
K110814Ambit TunnelerBSO · Abbreviated Summit Medical Products, Inc.04/08/2011SE
K102594Io-Flex CatheterBSO · Traditional Baxano, Inc.01/19/2011SE
K102460Ambit Introducer, Ambit Needle, Ambit SheathBSO · Abbreviated Summit Medical Products, Inc.01/13/2011SE
K093920Busse Epidural Catheter KitBSO · Traditional Busse Hospital Disposables08/06/2010SE
K090884Perifix One Pediatric Catheter, 20 Ga. & 24 Ga.BSO · Traditional B.Braun Medical, Inc.06/29/2009SE
K081404Spinal Integration Spinal-Eze Intraoperative Epidural Catheter KitBSO · Traditional Spinal Integration, LLC10/21/2008SE
K080675Pajunk Infiltralong Wound Infiltration Catheter KitBSO · Traditional PAJUNK GmbH Medizintechnologie06/20/2008SE
K072702Stryker Antimic CatheterBSO · Traditional Stryker Instruments, Instruments Div.03/19/2008SE
K072050Prolong-Ex, Models: PLEX-50CS, PLEX-100CS, PLEX-150CSBSO · Traditional Life-Tech, Inc.10/18/2007SE
K070465Busse Epidural CatheterBSO · Traditional Busse Hospital Disposables, Inc.07/19/2007SE
K063234On-Q IntroducersBSO · Abbreviated I-Flow Corp.11/21/2006SE
K062005Portex Epidural CatheterBSO · Special Smiths Medical Asd, Inc.10/18/2006SE
K051401On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterBSO · Traditional I-Flow Corp.11/30/2005SE
K051524Lock-It Plus Regional Anesthesia Catheter Securement Device, Model 100/399/216BSO · Traditional Smiths Medical Asd, Inc.07/07/2005SE
K050557Amt NanocathBSO · Traditional American Medical Technologies, Inc.05/27/2005SE
K043456Modification to Soaker CatheterBSO · Special I-Flow Corp.01/11/2005SE
K042488Perifix Catheter and Contiplex CatheterBSO · Traditional B.Braun Medical, Inc.09/30/2004SE
K032390Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter SystemBSO · Special Ebi, L.P.08/29/2003SE
K023140Versa-Kath Epidural Catheter, Model 156-2124BSO · Traditional Epimed International, Inc.08/15/2003SE
K023233Ebi Targetcath Fluoro-Guided Steerable Catheter SystemBSO · Traditional Ebi, L.P.12/13/2002SE
K022019Perifix Catheter ConnectorBSO · Traditional B.Braun Medical, Inc.08/01/2002SE
K991259Te Me Na Epidural CatheterBSO · Traditional Te ME NA S.A.R.L.02/21/2001SE
K000886Spirol Epidural CatheterBSO · Traditional Abbott Laboratories10/05/2000SE
K001717Micor Conduction CatheterBSO · Traditional Micor, Inc.09/20/2000SE
K993592Axiom Multipurpose Wound DrainBSO · Traditional Axiom Medical, Inc.05/17/2000SE
K991879Spring-Wound Epidural CatheterBSO · Traditional Micor, Inc.10/28/1999SE
K992471Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18BSO · Traditional Sims Portex, Inc.10/22/1999SE
K981329Feth-R-KathBSO · Traditional Epimed International, Inc.08/26/1998SE
K971851Interpleural Anesthesia CatheterBSO · Traditional Axiom Medical, Inc.01/22/1998SE
K951927Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter)BSO · Traditional Csen , Ltd.05/30/1997SE
K954584Racz Epidural CatheterBSO · Traditional Medic Evaluation Devices & Instruments Corp.10/08/1996SE
K951092Catheter Securement DeviceBSO · Traditional Baxter Healthcare Corp03/24/1995SE
K935927Concord/Portex Epidural CathetersBSO · Traditional Smiths Industries Medical Systems, Inc.09/09/1994SE
K930539Medcomp(R) Continuous Anesthesia TrayBSO · Traditional Medical Components, Inc.08/27/1993SE
K930219Kendall Curity 20 Gauge Continuous Epidual AnestheBSO · Traditional Kendall Healthcare Products Co. Div.Of Tyco Health04/27/1993SE
K9249954 Sure TM Anesthesia Extension SetBSO · Traditional Boston Pacific Medical, Inc.12/30/1992SE
K922113Kendall Curity Continuous Epiddual Anesthesia CathBSO · Traditional Kendall Healthcare Products Co. Div.Of Tyco Health12/03/1992SE
K897194Pharmaseal Epidural Catheter & Continuous EpiduralBSO · Traditional Baxter Healthcare Corp06/18/1990SE
K896712Pharmaseal Epidural CatheterBSO · Traditional Baxter Healthcare Corp06/18/1990SE
K901129Bio-Mate(Tm) Pediatric Epidural CatheterBSO · Traditional Medevice, Inc.03/30/1990SE
K895204Epi-Cath(Tm) Epidural CatheterBSO · Traditional Abbott Laboratories11/15/1989SE
K884969Bio-Mate(Tm) Epidural CatheterBSO · Traditional Medevice, Inc.06/23/1989SE
K863792Duracath, Gish Model No. Dvac-XxxxBSO · Traditional Gish Biomedical, Inc.12/05/1986SE
K854601Spring Guide Catheter Anesthesia Conduction CathBSO · Traditional Concord Laboratories, Inc.01/10/1986SE
K850009Evans, Vas-Cath Epidural Needle & CatheterBSO · Traditional Vas-Cath of Canada , Ltd.05/13/1985SE
K850505Deseret Epidural Catheter W/Toughy-Borst AdapterBSO · Traditional Parke-Davis Co.03/11/1985SE
K850439Deseret Epidural CatheterBSO · Traditional Parke-Davis Co.03/05/1985SE
K840202Epidural CatheterBSO · Traditional Aries Medical, Inc.02/27/1984SE
K8323523-DAY Release of Ethylene Oxide DeviceBSO · Traditional Parke-Davis Co.01/13/1984SE
K832232Epineed Epidural CatheterBSO · Traditional Terumo Medical Corp.08/08/1983SE
K823702Epidural CatheterBSO · Traditional Rsp, Inc.01/07/1983SE
K822436DNA Medical DuracathBSO · Traditional Moorehead Hospital Products, Inc.10/22/1982SE
K802065Continuous Epidural Anesthesia Tray/DrugBSO · Traditional Portex, Inc.09/09/1980SE

Recalls

RecallProductFirmInitiated
Z-2371-2026 Class IDescription/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… Arrow International, LLC04/21/2026Open, Classified
Z-1913-2026 Class IIFLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER…Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Arrow International, LLC03/11/2026Open, Classified
Z-1276-2021 Class IIFeth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #:…Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off Epimed International, Inc.02/01/2021Terminated
Z-2288-2020 Class IIArrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes…Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. Arrow International Inc05/08/2020Open, Classified
Z-1211-2020 Class IIFlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1207-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKPThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1206-2020 Class IIFlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIPThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1203-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-EThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1193-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code CA-02220There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1185-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSCThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1184-2020 Class IIFlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WHThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1182-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BIDThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1178-2020 Class IIFlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BIDThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1177-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code AK-05500There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1174-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRHThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1172-2020 Class IIFlexTip Plus Epidural Catheterization Kit, Product Code AK-05501There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits… Arrow International Inc01/15/2020Terminated
Z-1238-2020 Class IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CANProduct lidstock contains the incorrect expiration date for the product Arrow International Inc12/20/2019Terminated
Z-1237-2020 Class IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSCProduct lidstock contains the incorrect expiration date for the product Arrow International Inc12/20/2019Terminated
Z-1236-2020 Class IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1Product lidstock contains the incorrect expiration date for the product Arrow International Inc12/20/2019Terminated
Z-2069-2019 Class IIVersa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile…Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit… Epimed International, Inc.06/18/2019Terminated
Z-2068-2019 Class IIVersa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile…Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit… Epimed International, Inc.06/18/2019Terminated
Z-3405-2018 Class IIBULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection device used…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3404-2018 Class IIDESIGN OPTIONS PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3403-2018 Class IIEPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3402-2018 Class IIEC20C 20G X 100CM CATH CLOSED, Material Number 333540 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3401-2018 Class IIEC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3400-2018 Class IIEC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3399-2018 Class IIEC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3398-2018 Class IIEC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3397-2018 Class IIEC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3396-2018 Class IIEC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3395-2018 Class IINES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3394-2018 Class IIES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3393-2018 Class IIES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3392-2018 Class IIESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3391-2018 Class IIES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3390-2018 Class IIES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3389-2018 Class IIES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3388-2018 Class IIGOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3387-2018 Class IIGOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3386-2018 Class IIGOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3385-2018 Class IIGOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3384-2018 Class IICEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3383-2018 Class IIEPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3382-2018 Class IICEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3381-2018 Class IICLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connection device used…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3380-2018 Class IICLAMP STYLE CATHETER CONNECTOR 20GA- LF, Material Number 332283 Connection device used…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3379-2018 Class IICE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3378-2018 Class IICE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated
Z-3377-2018 Class IICCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used by…The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the… B. Braun Medical, Inc.07/20/2018Terminated