Perifix Catheter and Contiplex Catheter
FDA 510(k) K042488 · B.Braun Medical, Inc.
510(k) numberK042488
Submission
- Device name
- Perifix Catheter and Contiplex Catheter
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- September 13, 2004
- Decision date
- September 30, 2004
- 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 |
|---|---|---|
| K254111 | Irrigation/Urology SetsLJH · Traditional | 09/10/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | 05/15/2026SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | 07/24/2025SE |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemDTK · Traditional | 07/31/2024SE |
| K241845 | Introcan Safety® 2 IV CatheterFOZ · Special | 07/26/2024SE |
| K241385 | Omnifix Syringe NRFitQEH · Traditional | 07/13/2024SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | 09/15/2023SE |
| K223479 | AQUAbase nXFIP · Traditional | 08/16/2023SE |
| K220756 | Introcan Safety 2 IV CatheterFOZ · Special | 06/23/2022SE |
| K220626 | Introcan Safety IV CatheterFOZ · Special | 05/14/2022SE |
Questions and answers
When was Perifix Catheter and Contiplex Catheter cleared by the FDA?
Perifix Catheter and Contiplex Catheter (K042488) received a 510(k) decision of Substantially Equivalent on September 30, 2004, 17 days after the submission was received.
What is the product code of K042488?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.