PRECLUDE DURA SUBSTITUTE
FDA 510(k) clearance K953969 · decided 1995-11-01
Clearance details
- K-number
- K953969
- Device name
- PRECLUDE DURA SUBSTITUTE
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-22
- Decision date
- 1995-11-01
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- GXQ
- Device class
- 2
- Regulation number
- 882.5910
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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| XenoSure Dura Biologic Patch (K183513) | LeMaitre Vascular, Inc. | 2019-06-13 |
| Cerafix Dura Substitute (K172603) | Acera Surgical, Inc. | 2017-11-27 |
| DuraGen Secure Dural Regeneration Matrix (K163456) | Integra LifeSciences Corporation | 2017-01-06 |
| Durepair Dura Regeneration Matrix (K161370) | Medtronic Neurosurgery | 2016-11-02 |
| Cerafix Dura Substitute (K161278) | Acera Surgical, Inc. | 2016-08-08 |
| Cerafix Dura Substitute (K153613) | Acera Surgical, Inc. | 2016-03-16 |
| Collagen Dural Regeneration Matrix (K150825) | Collagen Matrix, Inc. | 2015-11-20 |
| DURAFORM Dural Graft Implant (K152481) | Codman & Shurtleff, Inc. | 2015-10-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® VIABAHN® FORTEGRA Venous Stent (P250017) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048) | W. L. Gore & Associates, Inc. | 2025-11-24 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099) | W. L. Gore & Associates, Inc. | 2025-10-27 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049) | W. L. Gore & Associates, Inc. | 2025-10-17 |