Dignity Power Injectable Titanium Port
FDA 510(k) K120281 · Medical Components, Inc.
510(k) numberK120281
Submission
- Device name
- Dignity Power Injectable Titanium Port
- Applicant
- Medical Components, Inc.
Harleysville, PA, US - Received
- January 31, 2012
- Decision date
- September 17, 2012
- 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 |
| K153238 | Dignity Dual PortLJT · Traditional | Medcomp ( Medical Components) | 03/15/2016SE |
More from Medcomp ( Medical Components)
| 510(k) | Device | Decision |
|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | 08/12/2025SE |
| K141633 | Pro-Picc with Valve TechnologyLJS · Traditional | 09/29/2014SE |
| K132880 | Medcomp Power Injectable Safety Huber NeedleFPA · Traditional | 01/08/2014SE |
| K131687 | 6F X 60CM Triple Pro-Line CT Basic Ir SetLJS · Traditional | 08/16/2013SE |
| K130687 | 2F & 3F Vascu-Sheath Tearaway IntroducerDYB · Traditional | 08/15/2013SE |
| K130923 | 5F Dignity CT Titanium PortLJT · Traditional | 07/31/2013SE |
| K124046 | Valved Tearaway Introducer Generation IIDYB · Traditional | 06/03/2013SE |
| K123617 | 3F Pro-PiccLJS · Traditional | 05/15/2013SE |
| K122423 | Vasu-PiccLJS · Traditional | 12/12/2012SE |
| K121848 | Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III…MSD · Special | 09/21/2012SESK |
Questions and answers
When was Dignity Power Injectable Titanium Port cleared by the FDA?
Dignity Power Injectable Titanium Port (K120281) received a 510(k) decision of Substantially Equivalent on September 17, 2012, 230 days after the submission was received.
What is the product code of K120281?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.