| Device |
central venous catheter with manual insertion system |
| Regulation Description |
Intravascular catheter. |
| Definition |
A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted vessel. |
| Physical State |
The central venous catheter consists of a thin, flexible plastic tube. The insertion system combines common insertion components (such as a syringe, guidewire, and introducer needle) in order to facilitate the insertion procedure and is supplied pre-assembled with the catheter as one system. |
| Technical Method |
The catheter is inserted into the central venous system for delivery of fluids or medications, blood withdrawal, central venous pressure monitoring, or power injection of contrast media. The insertion system is supplied pre-assembled and pre-attached to the catheter and is used to facilitate the insertion of the catheter. |
| Target Area |
The catheter is inserted into the central vascular system (subclavian, internal jugular, or femoral veins). |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | SEF |
|---|
| Premarket Review |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5200
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
