510(k) DEN180062
- Device
- EchoTip Insight Portosystemic Pressure Gradient Measuring System
- Applicant
- Cook Ireland, Ltd.
- 510(k) number
- DEN180062
- Product code
- QIJ
- Decision
- Unknown (DENG)
- Decision date
- 2019-11-20
- Date received
- 2018-11-19
- Regulation
- 876.1050
- Classification name
- Endoscopic Transhepatic Venous Access Needle
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jane Kennedy
- Address
- O' Halloran Rd., National Technology Park Limerick IE
FDA Registration Numbers#
- 3009526575
- 3001845648
- 3005580113
Source Documents#
510(k) summary PDF not indicated by FDA