Te Me Na Epidural Catheter
FDA 510(k) K991259 · Te ME NA S.A.R.L.
510(k) numberK991259
Submission
- Device name
- Te Me Na Epidural Catheter
- Applicant
- Te ME NA S.A.R.L.
Oldsmar, FL, US - Received
- April 13, 1999
- Decision date
- February 21, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
Other 510(k)s with product code BSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241410 | EDEN ControlCathBSO · Traditional | Jmt Co., Ltd. | 02/13/2025SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | B.Braun Medical, Inc. | 09/15/2023SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | Teleflex Medical | 08/30/2023SE |
| K193664 | SubQKath Catheter and Needle SetBSO · Traditional | Hk Surgical | 09/09/2020SE |
| K200624 | Percutaneous IntroducerBSO · Traditional | Epimed International, Inc. | 04/27/2020SE |
| K191470 | C-CAT Anaesthesia Catheter kitBSO · Traditional | Cimpax Aps | 10/25/2019SE |
| K181782 | Medline Reinforced Epidural CatheterBSO · Traditional | Medline Industries, Inc. | 03/04/2019SE |
| K173541 | EpinautBSO · Traditional | Imedicom Co., Ltd. | 08/24/2018SE |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional | PAJUNK GmbH Medizintechnologie | 05/03/2018SE |
| K171584 | B. Braun Tear-Away Introducer NeedleBSO · Traditional | B.Braun Medical, Inc. | 12/22/2017SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990323 | Te Me Na Polystim Nerve StimilatorBXN · Traditional | 09/28/2001SE |
| K002405 | Spinal Epidural NeedlesBSP · Traditional | 06/01/2001SE |
| K990100 | Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation NeedleGXZ · Traditional | 08/02/2000SE |
| K990020 | Te Me Na Loss of Resistance Syringe, 10CCFMF · Traditional | 06/24/1999SE |
Questions and answers
When was Te Me Na Epidural Catheter cleared by the FDA?
Te Me Na Epidural Catheter (K991259) received a 510(k) decision of Substantially Equivalent on February 21, 2001, 680 days after the submission was received.
What is the product code of K991259?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.