21 CFR 880.5970 — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5970
Identification
A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
Classification Rationale
Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 302 | Implant |
| ODY | Tunneled Catheter Remover | 2 | 2 | |
| OKC | Implanted Subcutaneous Securement Catheter | 2 | 5 | Implant |
| OMF | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position | 2 | 2 | Implant |
| PWR | Catheter Repair Kit | 2 | 0 | |
| PZW | Catheter Access Cover, Tamper-Resistant | 2 | 2 |
Special Controls
LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
eCFR
LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Ecfr Llm
ODY — Tunneled Catheter Remover
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
eCFR
OKC — Implanted Subcutaneous Securement Catheter
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
eCFR
OMF — Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
eCFR
PWR — Catheter Repair Kit
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
eCFR
PZW — Catheter Access Cover, Tamper-Resistant
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
eCFR
