P.A.S. Port Elite Implantable Venous Access System
FDA 510(k) K992880 · Sims Deltec, Inc.
510(k) numberK992880
Submission
- Device name
- P.A.S. Port Elite Implantable Venous Access System
- Applicant
- Sims Deltec, Inc.
St. Paul, MN, US - Received
- August 27, 1999
- Decision date
- October 19, 1999
- 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 |
|---|---|---|
| K010426 | Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone CatheterLJT · Traditional | 03/08/2001SE |
| K000842 | Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemFRN · Traditional | 06/08/2000SE |
| K000942 | Cadd Checkvalve Administration Set, Model 21-7090FPA · Traditional | 04/27/2000SE |
| K994216 | Plastic Port Implantable Venous Access SystemLJT · Traditional | 01/27/2000SE |
| K992697 | Port-A-Cath II Trans-Arterial Percutaneous SystemLJT · Traditional | 11/18/1999SE |
| K991599 | Cadd Administration SetFPA · Traditional | 06/15/1999SE |
| K991301 | Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-On Anti-Siphon…FPA · Traditional | 06/09/1999SE |
| K991255 | Cadd-Tpn Administration Set, Model 21-7071FPA · Traditional | 06/09/1999SE |
| K990083 | Cadd Administration Set, Cadd 250ML Flexible Medication Reservoir, Modified Securit…FPA · Traditional | 02/12/1999SE |
| K984055 | Clinicath Polyflow Polyurethane Peripherally Inserted CathetersFOZ · Traditional | 01/29/1999SE |
Questions and answers
When was P.A.S. Port Elite Implantable Venous Access System cleared by the FDA?
P.A.S. Port Elite Implantable Venous Access System (K992880) received a 510(k) decision of Substantially Equivalent on October 19, 1999, 53 days after the submission was received.
What is the product code of K992880?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.