EchoTip Insight Portosystemic Pressure Gradient Measuring System
FDA 510(k) clearance DEN180062 · decided 2019-11-20
Clearance details
- K-number
- DEN180062
- Device name
- EchoTip Insight Portosystemic Pressure Gradient Measuring System
- Applicant
- Cook Ireland, Ltd.
- Decision
- Unknown
- Date received
- 2018-11-19
- Decision date
- 2019-11-20
- Days to decision
- 366 days
- Clearance type
- Direct
- Product code
- QIJ
- Device class
- 2
- Regulation number
- 876.1050
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Limerick, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zilver Flex® 35 Vascular Stent (P050017/S025) | Cook Ireland, Ltd. | 2025-10-22 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S044) | Cook Ireland, Ltd. | 2025-07-03 |
| Zilver Flex(R) 35 Vascular Stent (P050017/S024) | Cook Ireland, Ltd. | 2025-07-01 |
| Zilver PTX Peripheral Drug-Eluting Stent (P100022/S043) | Cook Ireland, Ltd. | 2024-12-20 |
| Zilver® Vascular Stent (P050017/S023) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S008) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S007) | Cook Ireland, Ltd. | 2024-02-08 |
| Zilver® PTX® Peripheral Drug- Eluting Stent (P100022/S042) | Cook Ireland, Ltd. | 2023-09-22 |