LJT · Port & Catheter, Implanted, Subcutaneous, Intravascular
General Hospital · 21 CFR 880.5965 · Class 2
Overview
| Product Code | LJT |
|---|---|
| Device Name | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Regulation | 21 CFR 880.5965 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| Implant | Yes |
Identification
A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.
Classification Rationale
Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
Recent Cleared Devices (20 of 287)
Showing 20 most recent of 287 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Bard Access Systems, Inc. | Sep 5, 2025 | SESE |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Bard Access Systems, Inc. | Jun 18, 2025 | SESE |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Bard Access Systems, Inc. | Oct 31, 2024 | SESE |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port | Bard Peripheral Vascular, Inc. | Dec 8, 2023 | SESE |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | May 22, 2020 | SESE |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | Jul 8, 2019 | SESE |
| K151239 | NMI DUAL PORT II | Navilyst Medical, Inc. | Jun 6, 2016 | SESE |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | C.R. Bard, Inc. | May 20, 2016 | SESE |
| K153238 | Dignity Dual Port | Medcomp ( Medical Components) | Mar 15, 2016 | SESE |
| K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | Dec 4, 2015 | SESE |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | C.R. Bard, Inc. | Nov 20, 2015 | SESE |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | Cook Incorporated | May 21, 2015 | SESE |
| K141146 | INVISIPORT | Stealth Therapeutics, Incorporated | May 1, 2015 | SESE |
| K140169 | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | Cook Incorporated | May 21, 2014 | SESE |
| K133335 | POWERPORT IMPLANTABLE PORT | C.R. Bard, Inc. | Feb 14, 2014 | SESE |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | Medcomp ( Medical Components) | Dec 12, 2013 | SESE |
| K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | Perouse Medical | Dec 11, 2013 | SESE |
| K131694 | NMI PORT II CATHETER | Navilyst Medical, Inc. | Aug 8, 2013 | SESE |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Medical Components, Inc. | Jul 31, 2013 | SESE |
| K122402 | LPP (LOW PROFILE PORT) | Pfm Medical, Inc. | Jul 16, 2013 | SESE |
Top Applicants
- Strato Medical Corp. — 27 clearances
- Therex Corp. — 24 clearances
- C.R. Bard, Inc. — 22 clearances
- Med Institute, Inc. — 17 clearances
- Norfolk Medical Products, Inc. — 14 clearances
