Norfolk Medical-Sportport-Family of Ports
FDA 510(k) K112713 · Norfolk Medical Products, Inc.
510(k) numberK112713
Submission
- Device name
- Norfolk Medical-Sportport-Family of Ports
- Applicant
- Norfolk Medical Products, Inc.
Skokie, IL, US - Received
- September 19, 2011
- Decision date
- October 27, 2011
- 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 |
| 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 |
More from Medcomp ( Medical Components)
| 510(k) | Device | Decision |
|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access PortPTD · Traditional | 08/20/2020SE |
| K102385 | Norfolk Medical Norport Family of PortsLJT · Traditional | 01/14/2011SE |
| K942784 | Norfolk Omega Port-Lp Subcutaneously ImplantedLJT · Traditional | 05/02/1995SE |
| K896544 | MD2 Personal Infusion SystemFRN · Traditional | 05/02/1990SE |
| K872838 | Norfolk Norport (TM) -Sp (Skin Parallel)LJT · Traditional | 08/25/1987SE |
| K871209 | Norfolk Medical NorportLJT · Traditional | 06/24/1987SE |
| K871192 | Subcutaneously Implanted Drug Delivery DepotLJT · Traditional | 06/10/1987SE |
| K870187 | Norfolk Norport, Subcut. Implanted Drug Del. DepotLJT · Traditional | 05/07/1987SE |
| K870519 | Subcutaneously Implanted Drug Delivery DepotLJT · Traditional | 04/15/1987SE |
| K870188 | Norfolk Medical Butterfly Infusion SetFPA · Traditional | 02/10/1987SE |
Questions and answers
When was Norfolk Medical-Sportport-Family of Ports cleared by the FDA?
Norfolk Medical-Sportport-Family of Ports (K112713) received a 510(k) decision of Substantially Equivalent on October 27, 2011, 38 days after the submission was received.
What is the product code of K112713?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.