| Device |
catheter access cover, tamper-resistant |
| Regulation Description |
Percutaneous, implanted, long-term intravascular catheter. |
| Definition |
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter |
| Physical State |
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter. The device is designed to fit over the tip of the exposed IV line and is locked to prevent access |
| Technical Method |
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter. The device is designed to fit over the tip of the exposed IV line and is locked to prevent access |
| Target Area |
Hub or Luer access of an intravenous catheter |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PZW |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5970
|
|---|
| 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 |
