QIJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Transhepatic Venous Access Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1050
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- An endoscopic transhepatic venous access needle is inserted through the liver into the patients portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.
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| Record | Firm | Date |
|---|---|---|
| EchoTip Insight Portosystemic Pressure Gradient Measuring System (DEN180062) | Cook Ireland, Ltd. | 2019-11-20 |
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