Nmi Dual Port II
FDA 510(k) K151239 · Navilyst Medical, Inc.
510(k) numberK151239
Submission
- Device name
- Nmi Dual Port II
- Applicant
- Navilyst Medical, Inc.
Marlborough, MA, US - Received
- May 11, 2015
- Decision date
- June 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
|---|---|---|
| K163452 | PICC Maximal Barrier Nursing KitLJS · Special | 02/03/2017SESK |
| K161866 | BioFlo Midline CatheterFOZ · Traditional | 09/08/2016SE |
| K153228 | NMI Port, NMI Port IILJT · Special | 12/04/2015SE |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCLJS · Special | 09/24/2015SE |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…FGE · Traditional | 09/24/2015SE |
| K150407 | BioFlo Midline CatheterFOZ · Abbreviated | 05/15/2015SE |
| K150527 | Xcela Power Injectable PICCLJS · Special | 03/31/2015SE |
| K150448 | NMI PICC III and NMI PICC IVLJS · Special | 03/19/2015SE |
| K142616 | PICC Maximal Barrier Nursing KitLJS · Special | 10/14/2014SE |
| K140194 | Namic RCS SyringeFMF · Abbreviated | 04/14/2014SE |
Questions and answers
When was Nmi Dual Port II cleared by the FDA?
Nmi Dual Port II (K151239) received a 510(k) decision of Substantially Equivalent on June 6, 2016, 392 days after the submission was received.
What is the product code of K151239?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.