Powerport Duo M.R.I. Implanted Port with 9.5 Fr. Dual Lumen Chronoflex Polyurethane Catheter
FDA 510(k) K090512 · C.R. Bard, Inc.
510(k) numberK090512
Submission
- Device name
- Powerport Duo M.R.I. Implanted Port with 9.5 Fr. Dual Lumen Chronoflex Polyurethane Catheter
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- February 26, 2009
- Decision date
- March 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| 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 |
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Questions and answers
When was Powerport Duo M.R.I. Implanted Port with 9.5 Fr. Dual Lumen Chronoflex Polyurethane Catheter cleared by the FDA?
Powerport Duo M.R.I. Implanted Port with 9.5 Fr. Dual Lumen Chronoflex Polyurethane Catheter (K090512) received a 510(k) decision of Substantially Equivalent on March 27, 2009, 29 days after the submission was received.
What is the product code of K090512?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.