Interpleural Anesthesia Catheter
FDA 510(k) K971851 · Axiom Medical, Inc.
510(k) numberK971851
Submission
- Device name
- Interpleural Anesthesia Catheter
- Applicant
- Axiom Medical, Inc.
Rancho Dominguez, CA, US - Received
- May 20, 1997
- Decision date
- January 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K993592 | Axiom Multipurpose Wound DrainBSO · Traditional | 05/17/2000SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | 03/10/1997SE |
| K934895 | Glassman Silicone CatheterEZL · Traditional | 10/13/1994SE |
| K922760 | Atraum Wound Dressing--ModificationKMF · Traditional | 10/30/1992SE |
| K905422 | PVC Round Wound DrainsGBX · Traditional | 02/11/1991SE |
| K904218 | Suction SystemGEA · Traditional | 10/31/1990SE |
| K904133 | Disposable Fluid Collection BagGBX · Traditional | 10/11/1990SE |
| K863247 | Axiom Trocar Thoracic CatheterGBS · Traditional | 08/29/1986SE |
| K861306 | Suction SystemGEA · Traditional | 06/09/1986SE |
| K852614 | Atraum Wound DressingFRO · Traditional | 08/30/1985SE |
Questions and answers
When was Interpleural Anesthesia Catheter cleared by the FDA?
Interpleural Anesthesia Catheter (K971851) received a 510(k) decision of Substantially Equivalent on January 22, 1998, 247 days after the submission was received.
What is the product code of K971851?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.