BSO · Catheter, Conduction, Anesthetic
Anesthesiology · 21 CFR 868.5120 · Class 2
Overview
| Product Code | BSO |
|---|---|
| Device Name | Catheter, Conduction, Anesthetic |
| Regulation | 21 CFR 868.5120 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.
Classification Rationale
Class II (performance standards).
Cleared Devices (75)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241410 | EDEN ControlCath | Jmt Co., Ltd. | Feb 13, 2025 | SESE |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | Sep 15, 2023 | SESE |
| K230603 | 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 Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) | Teleflex Medical | Aug 30, 2023 | SESE |
| K193664 | SubQKath Catheter and Needle Set | Hk Surgical | Sep 9, 2020 | SESE |
| K200624 | Percutaneous Introducer | Epimed International, Inc. | Apr 27, 2020 | SESE |
| K191470 | C-CAT Anaesthesia Catheter kit | Cimpax Aps | Oct 25, 2019 | SESE |
| K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | Mar 4, 2019 | SESE |
| K173541 | EPINAUT | Imedicom Co., Ltd. | Aug 24, 2018 | SESE |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 | PAJUNK GmbH Medizintechnologie | May 3, 2018 | SESE |
| K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | Dec 22, 2017 | SESE |
| K171193 | Certa Catheter | Ferrosan Medical Devices Sp. Z.O.O. | Dec 18, 2017 | SESE |
| K162522 | UltraCath Continuous Nerve block Catheter | Teleflexmedical, Inc. | Mar 17, 2017 | SESE |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | Halyard Health | Sep 30, 2016 | SESE |
| K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | Aug 12, 2016 | SESE |
| K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | Jul 13, 2016 | SESE |
| K150731 | Medline Epidural Catheter | Medline Industries, Inc. | Mar 7, 2016 | SESE |
| K150789 | SPINAUT-E, SPINAUT-I | Imedicom Co., Ltd. | Mar 1, 2016 | SESE |
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | Teleflex, Inc. | Mar 27, 2015 | SESE |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | Kimberly-Clark Corporation | Dec 2, 2014 | SESE |
| K133316 | SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) | Epimed International, Inc. | May 28, 2014 | SESE |
| K122661 | VITAL 5 RELEAF CATHETER | Vital 5 | Feb 27, 2013 | SESE |
| K111031 | PAINFUSOR CATHETER | Plan 1 Health, S.R.L. | Jul 8, 2011 | SESE |
| K110814 | AMBIT TUNNELER | Summit Medical Products, Inc. | Apr 8, 2011 | SESE |
| K102594 | IO-FLEX CATHETER | Baxano, Inc. | Jan 19, 2011 | SESE |
| K102460 | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH | Summit Medical Products, Inc. | Jan 13, 2011 | SESE |
| K093920 | BUSSE EPIDURAL CATHETER KIT | Busse Hospital Disposables | Aug 6, 2010 | SESE |
| K090884 | PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. | B.Braun Medical, Inc. | Jun 29, 2009 | SESE |
| K081404 | SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT | Spinal Integration, LLC | Oct 21, 2008 | SESE |
| K080675 | PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT | PAJUNK GmbH Medizintechnologie | Jun 20, 2008 | SESE |
| K072702 | STRYKER ANTIMIC CATHETER | Stryker Instruments, Instruments Div. | Mar 19, 2008 | SESE |
| K072050 | PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS | Life-Tech, Inc. | Oct 18, 2007 | SESE |
| K070465 | BUSSE EPIDURAL CATHETER | Busse Hospital Disposables, Inc. | Jul 19, 2007 | SESE |
| K063234 | ON-Q INTRODUCERS | I-Flow Corp. | Nov 21, 2006 | SESE |
| K062005 | PORTEX EPIDURAL CATHETER | Smiths Medical Asd, Inc. | Oct 18, 2006 | SESE |
| K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER | I-Flow Corp. | Nov 30, 2005 | SESE |
| K051524 | LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 | Smiths Medical Asd, Inc. | Jul 7, 2005 | SESE |
| K050557 | AMT NANOCATH | American Medical Technologies, Inc. | May 27, 2005 | SESE |
| K043456 | MODIFICATION TO SOAKER CATHETER | I-Flow Corp. | Jan 11, 2005 | SESE |
| K042488 | PERIFIX CATHETER AND CONTIPLEX CATHETER | B.Braun Medical, Inc. | Sep 30, 2004 | SESE |
| K032390 | MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM | Ebi, L.P. | Aug 29, 2003 | SESE |
| K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 | Epimed International, Inc. | Aug 15, 2003 | SESE |
| K023233 | EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM | Ebi, L.P. | Dec 13, 2002 | SESE |
| K022019 | PERIFIX CATHETER CONNECTOR | B.Braun Medical, Inc. | Aug 1, 2002 | SESE |
| K991259 | TE ME NA EPIDURAL CATHETER | Te ME NA S.A.R.L. | Feb 21, 2001 | SESE |
| K000886 | SPIROL EPIDURAL CATHETER | Abbott Laboratories | Oct 5, 2000 | SESE |
| K001717 | MICOR CONDUCTION CATHETER | Micor, Inc. | Sep 20, 2000 | SESE |
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | Axiom Medical, Inc. | May 17, 2000 | SESE |
| K991879 | SPRING-WOUND EPIDURAL CATHETER | Micor, Inc. | Oct 28, 1999 | SESE |
| K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | Sims Portex, Inc. | Oct 22, 1999 | SESE |
| K981329 | FETH-R-KATH | Epimed International, Inc. | Aug 26, 1998 | SESE |
| K971851 | INTERPLEURAL ANESTHESIA CATHETER | Axiom Medical, Inc. | Jan 22, 1998 | SESE |
| K951927 | COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER) | Csen , Ltd. | May 30, 1997 | SESE |
| K954584 | RACZ EPIDURAL CATHETER | Medic Evaluation Devices & Instruments Corp. | Oct 8, 1996 | SESE |
| K951092 | CATHETER SECUREMENT DEVICE | Baxter Healthcare Corp | Mar 24, 1995 | SESE |
| K935927 | CONCORD/PORTEX EPIDURAL CATHETERS | Smiths Industries Medical Systems, Inc. | Sep 9, 1994 | SESE |
| K930539 | MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY | Medical Components, Inc. | Aug 27, 1993 | SESE |
| K930219 | KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE | Kendall Healthcare Products Co. Div.Of Tyco Health | Apr 27, 1993 | SESE |
| K924995 | 4 SURE TM ANESTHESIA EXTENSION SET | Boston Pacific Medical, Inc. | Dec 30, 1992 | SESE |
| K922113 | KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH | Kendall Healthcare Products Co. Div.Of Tyco Health | Dec 3, 1992 | SESE |
| K897194 | PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL | Baxter Healthcare Corp | Jun 18, 1990 | SESE |
| K896712 | PHARMASEAL EPIDURAL CATHETER | Baxter Healthcare Corp | Jun 18, 1990 | SESE |
| K901129 | BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER | Medevice, Inc. | Mar 30, 1990 | SESE |
| K895204 | EPI-CATH(TM) EPIDURAL CATHETER | Abbott Laboratories | Nov 15, 1989 | SESE |
| K884969 | BIO-MATE(TM) EPIDURAL CATHETER | Medevice, Inc. | Jun 23, 1989 | SESE |
| K863792 | DURACATH, GISH MODEL NO. DVAC-XXXX | Gish Biomedical, Inc. | Dec 5, 1986 | SESE |
| K854601 | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH | Concord Laboratories, Inc. | Jan 10, 1986 | SESE |
| K850009 | EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER | Vas-Cath of Canada , Ltd. | May 13, 1985 | SESE |
| K850505 | DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER | Parke-Davis Co. | Mar 11, 1985 | SESE |
| K850439 | DESERET EPIDURAL CATHETER | Parke-Davis Co. | Mar 5, 1985 | SESE |
| K840202 | EPIDURAL CATHETER | Aries Medical, Inc. | Feb 27, 1984 | SESE |
| K832352 | 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE | Parke-Davis Co. | Jan 13, 1984 | SESE |
| K832232 | EPINEED EPIDURAL CATHETER | Terumo Medical Corp. | Aug 8, 1983 | SESE |
| K823702 | EPIDURAL CATHETER | Rsp, Inc. | Jan 7, 1983 | SESE |
| K822436 | DNA MEDICAL DURACATH | Moorehead Hospital Products, Inc. | Oct 22, 1982 | SESE |
| K802065 | CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG | Portex, Inc. | Sep 9, 1980 | SESE |
Top Applicants
- B.Braun Medical, Inc. — 6 clearances
- Epimed International, Inc. — 4 clearances
- Parke-Davis Co. — 3 clearances
- PAJUNK GmbH Medizintechnologie — 3 clearances
- I-Flow Corp. — 3 clearances
