21 CFR 880.5965 — Port & Catheter, Implanted, Subcutaneous, Intravascular
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5965
Identification
A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.
Classification Rationale
Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 287 | Implant |
| LLD | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal | 2 | 4 | Implant |
| OBK | Port, Protector/Cushion | 2 | 1 | |
| OKE | Port Introducer Kit | 2 | 0 | |
| PTD | Subcutaneous Implanted Apheresis Port | 2 | 3 | Implant |
| PXK | Vascular Access Port Kit | 2 | 0 |
Special Controls
LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
eCFR
LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
Ecfr Llm
LLD — Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
eCFR
OBK — Port, Protector/Cushion
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
eCFR
OKE — Port Introducer Kit
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
eCFR
PTD — Subcutaneous Implanted Apheresis Port
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
eCFR
PXK — Vascular Access Port Kit
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
eCFR
