Dignity Dual Port
FDA 510(k) K153238 · Medcomp ( Medical Components)
510(k) numberK153238
Submission
- Device name
- Dignity Dual Port
- Applicant
- Medcomp ( Medical Components)
Harleysville, PA, US - Received
- November 9, 2015
- Decision date
- March 15, 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 |
| 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 |
| K153228 | NMI Port, NMI Port IILJT · Special | Navilyst Medical, Inc. | 12/04/2015SE |
More from Navilyst Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171931 | Celerity ECG Cable Accessory PackLJS · Traditional | 10/26/2017SE |
| K162389 | Medcomp Vessel DilatorDRE · Traditional | 06/01/2017SE |
| K162271 | Pro-Lock CT Safety Infusion SetPTI · Traditional | 04/26/2017SE |
| K153246 | PTFE Super Sheath Introducer 2.1DYB · Special | 02/12/2016SE |
| K143238 | C3 WaveLJS · Traditional | 04/24/2015SE |
| K141151 | CT MidlineLJS · Traditional | 07/08/2014SE |
| K140799 | Celerity SysyemLJS · Traditional | 06/13/2014SE |
| K132177 | Medcomp Gen III Power Injectable PortLJT · Traditional | 12/12/2013SE |
| K132498 | Valved Tearaway Introducer Generation IIDYB · Special | 11/25/2013SE |
| K130897 | Medcomp Vascu-Picc with ValveLJS · Traditional | 10/22/2013SE |
Questions and answers
When was Dignity Dual Port cleared by the FDA?
Dignity Dual Port (K153238) received a 510(k) decision of Substantially Equivalent on March 15, 2016, 127 days after the submission was received.
What is the product code of K153238?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.