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).
Recent Cleared Devices (20 of 75)
Showing 20 most recent of 75 cleared devices.
| 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 |
Top Applicants
- B.Braun Medical, Inc. — 6 clearances
- Epimed International, Inc. — 4 clearances
- Baxter Healthcare Corp — 3 clearances
- I-Flow Corp. — 3 clearances
- PAJUNK GmbH Medizintechnologie — 3 clearances
