Endoscopic Transhepatic Venous Access Needle
The Endoscopic Transhepatic Venous Access Needle is a Class 2 gastroenterology device inserted through the liver into the patient's portal or hepatic venous system under endoscopic ultrasound guidance, and is connected to a separate device intended to measure a physiological parameter. It requires 510(k) clearance and is regulated under 21 CFR 876.1050 within the Gastroenterology and Urology medical specialty. The product code is QIJ. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QIJ
- Device Class
- FDA class 2
- Regulation Number
- 876.1050
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN180062 | EchoTip Insight Portosystemic Pressure Gradient Measuring System | Nov 20, 2019 | Unknown | Cook Ireland, Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.