Ipi Dual Lumen Port
FDA 510(k) K934167 · Pudenz-Schulte Medical Research Corp.
510(k) numberK934167
Submission
- Device name
- Ipi Dual Lumen Port
- Applicant
- Pudenz-Schulte Medical Research Corp.
Goleta, CA, US - Received
- August 27, 1993
- Decision date
- July 14, 1994
- 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 |
|---|---|---|
| K960055 | Medtronic PS Medical Bioglide Vascular Catheter, SNGL Lumen Model Nos 8960 & 8932LJS · Traditional | 09/30/1996SE |
| K954409 | PS Medical Ipi Vascular Access CatheterLJS · Traditional | 12/18/1995SE |
| K951258 | PS Medical Bioglide Csf-Flow Control Shunt KitJXG · Traditional | 09/18/1995SE |
| K934796 | Ipi Low Profile ImportLJT · Traditional | 07/14/1994SE |
| K940096 | PS Medical Catheter Placement KitGWG · Traditional | 05/03/1994SE |
| K934545 | PS Medical Delta Burr Hole ValveJXG · Traditional | 04/28/1994SE |
| K930206 | PS Medical Ipi Access KitLJT · Traditional | 02/25/1994SESK |
| K930606 | PS Medical Disposable Subcutaneous Cath PasserGYK · Traditional | 09/10/1993SE |
| K913412 | PS Medical Csf-Access DeviceJXG · Traditional | 03/30/1993SE |
| K922419 | Ipi ImportLJT · Traditional | 11/20/1992SE |
Questions and answers
When was Ipi Dual Lumen Port cleared by the FDA?
Ipi Dual Lumen Port (K934167) received a 510(k) decision of Substantially Equivalent on July 14, 1994, 321 days after the submission was received.
What is the product code of K934167?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.