| Device |
endoscopic transhepatic venous access needle |
| Regulation Description |
Endoscopic transhepatic venous access needle. |
| Definition |
An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter. |
| Physical State |
An endoscopic transhepatic venous access needle connected to a separate device intended to measure a physiological parameter, which may have a connecting component to perform its function.physiological parameter. |
| Technical Method |
Measure Portal Venous/Hepatic Venous Pressures with needle and a pressure transducer or connected to a separate device to measure other physiological parameters |
| Target Area |
Liver, portal/hepatic veins |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | QIJ |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1050
|
|---|
| 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 |
