PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
FDA 510(k) K242328 · Bard Access Systems, Inc.
510(k) numberK242328
Submission
- Device name
- PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- Applicant
- Bard Access Systems, Inc.
Salt Lake Ciy,, UT, US - Received
- August 6, 2024
- Decision date
- October 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5965
- Specialty
- General Hospital
- Implant
- Yes
Other 510(k)s with product code LJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260916 | FLEXI-PORT Power Injectable Implantable PortLJT · Traditional | Portal Access, Inc. | 06/17/2026SE |
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable…LJT · Special | Bard Access Systems, Inc. | 09/05/2025SE |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special | Bard Access Systems, Inc. | 06/18/2025SE |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG…LJT · Special | Bard Peripheral Vascular, Inc. | 12/08/2023SE |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsLJT · Traditional | AngioDynamics, Inc. | 05/22/2020SE |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®)LJT · Traditional | C.R. Bard, Inc. | 07/08/2019SE |
| K151239 | Nmi Dual Port IILJT · Traditional | Navilyst Medical, Inc. | 06/06/2016SE |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted PortsLJT · Special | C.R. Bard, Inc. | 05/20/2016SE |
| K153238 | Dignity Dual PortLJT · Traditional | Medcomp ( Medical Components) | 03/15/2016SE |
| K153228 | NMI Port, NMI Port IILJT · Special | Navilyst Medical, Inc. | 12/04/2015SE |
More from Navilyst Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable…LJT · Special | 09/05/2025SE |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special | 06/18/2025SE |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle SetPTI · Traditional | 11/27/2024SE |
| K240146 | BD Prevue II Peripheral Vascular Access SystemIYO · Special | 02/18/2024SE |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003)MHC · Special | 11/10/2022SE |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyLJS · Special | 08/24/2022SE |
| K210264 | BD PowerPiCC CatheterLJS · Traditional | 07/30/2021SE |
| K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle GuideIYO · Traditional | 05/30/2012SE |
| K100402 | Site-Rite Vision Ultrasound SystemIYN · Traditional | 03/05/2010SE |
| K071095 | Aspira Pleural Drainage SystemDWM · Traditional | 05/18/2007SE |
Questions and answers
When was PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports cleared by the FDA?
PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports (K242328) received a 510(k) decision of Substantially Equivalent on October 31, 2024, 86 days after the submission was received.
What is the product code of K242328?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.