The following data is part of a De Novo classification by Cook Ireland Ltd. with the FDA for Echotip Insight Portosystemic Pressure Gradient Measuring System.
| DeNovo ID | DEN180062 |
| Device Name: | EchoTip Insight Portosystemic Pressure Gradient Measuring System |
| Classification | Endoscopic Transhepatic Venous Access Needle |
| Applicant | Cook Ireland Ltd. o'halloran Road, National Technology Park Limerick, IE |
| Contact | Jane Kennedy |
| Product Code | QIJ |
| CFR Regulation Number | 876.1050 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2018-11-19 |
| Decision Date | 2019-11-20 |
| Reclassification Order: | Reclassification Order |