QIJ — Endoscopic Transhepatic Venous Access Needle Class II
FDA product code QIJ covers "Endoscopic Transhepatic Venous Access Needle", a Class II medical device regulated under 21 CFR 876.1050. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QIJ
- Device Class
- Class II
- Regulation Number
- 876.1050
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180062 | cook ireland | EchoTip Insight Portosystemic Pressure Gradient Measuring System | November 20, 2019 |