GORE VIATORR TIPS
FDA premarket approval P040027 · decided 2004-12-06
Approval details
- PMA number
- P040027
- Trade name
- GORE VIATORR TIPS
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2004-06-09
- Decision date
- 2004-12-06
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Phonix, AZ
- Statement
- APPROVAL FOR THE GORE VIATORR TIPS ENDOPROSTHESIS. THE DEVICE IS INDICATED FOR USE IN DE NOVO AND REVISION TREATMENT OF PORTAL HYPERTENSION AND ITS COMPLICATIONS SUCH AS VARICEAL BLEEDING, GASTROPATHY, ASCITES, AND/OR HEPATIC HYDROTHORAX.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |