GORE-TEX TUNNELER
FDA 510(k) clearance K844584 · decided 1985-01-24
Clearance details
- K-number
- K844584
- Device name
- GORE-TEX TUNNELER
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-23
- Decision date
- 1985-01-24
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- DWS
- Device class
- 1
- Regulation number
- 870.4500
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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.
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|---|---|---|
| MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (K022238) | Medtronic Vascular | 2002-10-09 |
| OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (K964445) | Dlp, Inc. | 1997-01-30 |
| BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (K962771) | Pilling Weck, Inc. | 1996-11-19 |
| RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (K955689) | Contour Fabricators of Florida, Inc. | 1996-05-15 |
| G.E. STERILE ANGIOGRAPHIC TRAY (K960139) | GE Medical Systems | 1996-04-19 |
| G.E. STERILE CT BIOPSY TRAY (K960144) | GE Medical Systems | 1996-04-15 |
| G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (K960143) | GE Medical Systems | 1996-04-09 |
| REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (K934727) | Cardiac Pacemakers, Inc. | 1994-01-10 |
| HYCULT DIAMOND CORONARY BYPASS KNIFE (K900379) | St. Jude Medical, Inc. | 1990-03-19 |
| INSULATION PAD (K896307) | Bio-Vascular, Inc. | 1990-01-19 |
| MODEL 6888 LEAD TUNNELER (K894738) | Cardiac Pacemakers, Inc. | 1989-09-13 |
| NEWCHILL(TM) CARDIAC INSULATOR (K892804) | Acacia Laboratories, Inc. | 1989-07-14 |
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 |