A2 Port, Dual Lumen System with Detached Catheter, Catalog # AP-01518 (Modified)
FDA 510(k) K963684 · Arrow Intl., Inc.
510(k) numberK963684
Submission
- Device name
- A2 Port, Dual Lumen System with Detached Catheter, Catalog # AP-01518 (Modified)
- Applicant
- Arrow Intl., Inc.
Walpole, MA, US - Received
- August 12, 1996
- Decision date
- October 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 A2 Port, Dual Lumen System with Detached Catheter, Catalog # AP-01518 (Modified) cleared by the FDA?
A2 Port, Dual Lumen System with Detached Catheter, Catalog # AP-01518 (Modified) (K963684) received a 510(k) decision of Substantially Equivalent on October 24, 1996, 73 days after the submission was received.
What is the product code of K963684?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.