Product code BSO
- Device name
- Catheter, Conduction, Anesthetic
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5120
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241410 | EDEN ControlCath | Jmt Co., Ltd. | 2025-02-13 |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | 2023-09-15 |
| 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 Stimula... | Teleflex Medical | 2023-08-30 |
| K193664 | SubQKath Catheter and Needle Set | Hk Surgical | 2020-09-09 |
| K200624 | Percutaneous Introducer | Epimed International, Inc. | 2020-04-27 |
| K191470 | C-CAT Anaesthesia Catheter kit | Cimpax Aps | 2019-10-25 |
| K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | 2019-03-04 |
| K173541 | EPINAUT | Imedicom Co., Ltd. | 2018-08-24 |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 | PAJUNK GmbH Medizintechnologie | 2018-05-03 |
| K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | 2017-12-22 |
| K171193 | Certa Catheter | Ferrosan Medical Devices Sp. Z.O.O. | 2017-12-18 |
| K162522 | UltraCath Continuous Nerve block Catheter | Teleflexmedical, Inc. | 2017-03-17 |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | Halyard Health | 2016-09-30 |
| K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | 2016-08-12 |
| K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | 2016-07-13 |
| K150731 | Medline Epidural Catheter | Medline Industries, Inc. | 2016-03-07 |
| K150789 | SPINAUT-E, SPINAUT-I | Imedicom Co., Ltd. | 2016-03-01 |
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | Teleflex, Inc. | 2015-03-27 |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | Kimberly-Clark Corporation | 2014-12-02 |
| 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. | 2014-05-28 |
| K122661 | VITAL 5 RELEAF CATHETER | Vital 5 | 2013-02-27 |
| K111031 | PAINFUSOR CATHETER | Plan 1 Health, S.R.L. | 2011-07-08 |
| K110814 | AMBIT TUNNELER | Summit Medical Products, Inc. | 2011-04-08 |
| K102594 | IO-FLEX CATHETER | Baxano, Inc. | 2011-01-19 |
| K102460 | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH | Summit Medical Products, Inc. | 2011-01-13 |
| K093920 | BUSSE EPIDURAL CATHETER KIT | Busse Hospital Disposables | 2010-08-06 |
| K090884 | PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. | B.Braun Medical, Inc. | 2009-06-29 |
| K081404 | SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT | Spinal Integration, LLC | 2008-10-21 |
| K080675 | PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT | PAJUNK GmbH Medizintechnologie | 2008-06-20 |
| K072702 | STRYKER ANTIMIC CATHETER | Stryker Instruments, Instruments Div. | 2008-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809544172264 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172257 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172240 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172233 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172226 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172219 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172202 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172196 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172189 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172172 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172165 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172158 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809544172141 | EPINAUT | IMEDICOM CO., LTD. | 2018-09-21 |
| 08809317177878 | SPINAUT-I | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177885 | SPINAUT-I | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177861 | SPINAUT-I | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177366 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177359 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177342 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177335 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177328 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177311 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177304 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177298 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08809317177281 | SPINAUT-E | IMEDICOM CO., LTD. | 2016-12-16 |
| 08056459671218 | PAINfusor Catheter | PLAN 1 HEALTH S.R.L. | 2016-09-23 |
| 08056459671256 | PAINfusor Catheter | PLAN 1 HEALTH S.R.L. | 2016-09-23 |
| 08056459671249 | PAINfusor Catheter | PLAN 1 HEALTH S.R.L. | 2016-09-23 |
| 08056459671232 | PAINfusor Catheter | PLAN 1 HEALTH S.R.L. | 2016-09-23 |
| 08056459671225 | PAINfusor Catheter | PLAN 1 HEALTH S.R.L. | 2016-09-23 |