510(k) DEN180062
DEN180062 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "EchoTip Insight Portosystemic Pressure Gradient Measuring System". The FDA issued a decision of De Novo Granted on November 20, 2019. The device falls under product code QIJ (Endoscopic Transhepatic Venous Access Needle), a Class II device regulated under 21 CFR 876.1050. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 20, 2019
- Date Received
- November 19, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Transhepatic Venous Access Needle
- Device Class
- Class II
- Regulation Number
- 876.1050
- Review Panel
- GU
- Submission Type
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.