Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port
FDA 510(k) K252478 · Bard Access Systems, Inc.
510(k) numberK252478
Submission
- Device name
- Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port
- Applicant
- Bard Access Systems, Inc.
Salt Lake Ciy,, UT, US - Received
- August 7, 2025
- Decision date
- September 5, 2025
- 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 |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special | Bard Access Systems, Inc. | 06/18/2025SE |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable…LJT · Special | Bard Access Systems, Inc. | 10/31/2024SE |
| 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 |
|---|---|---|
| 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 |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable…LJT · Special | 10/31/2024SE |
| 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 Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port cleared by the FDA?
Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port (K252478) received a 510(k) decision of Substantially Equivalent on September 5, 2025, 29 days after the submission was received.
What is the product code of K252478?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.