GORE INTRODUCER SHEATH
FDA 510(k) clearance K013282 · decided 2001-12-14
Clearance details
- K-number
- K013282
- Device name
- GORE INTRODUCER SHEATH
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-02
- Decision date
- 2001-12-14
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- DBY
- Device class
- 1
- Regulation number
- 866.5520
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CONVOY ADVANCED DELIVERY SHEATH (K022067) | Boston Scientific | 2002-09-11 |
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K013919) | Baylis Medical Co., Inc. | 2002-02-22 |
| BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (K013304) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 |
| CONVOY ADVANCED DELIVERY SHEATH KIT (K013866) | Boston Scientific | 2001-12-14 |
| RHODAMINE-CONJUGATED ANTISERUM (K771144) | Kent Laboratories, Inc. | 1977-07-14 |
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 |