GORE PROPATEN Vascular Graft
- Primary DI
- 00733132605972
- Company
- W. L. Gore & Associates, Inc.
- Model
- H470080A
- Catalog number
- H470080A
- Device description
- HEP 4-7MM X 80CM US
- Published
- 2017-02-13
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 967358115
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- true
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00733132605972 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00733132605972 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 | Cardiovascular | 870.3450 | Y | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K062161 | 000 | GORE PROPATEN VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2006-11-09 | DSY |
GMDN Terms
| Term | Definition |
|---|
| Synthetic vascular graft | A sterile artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries. |
Device Sizes
| Type | Value | Text |
|---|
| Length | 80 Centimeter | |
| Lumen/Inner Diameter | 4 Millimeter | |
| Lumen/Inner Diameter | 7 Millimeter | |
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| +1(800)528-8763 | mpdcustomercare@wlgore.com |
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| 00733132663729 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS280702A | VNS280702A | 2026-01-08 |
| 00733132663736 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS280502A | VNS280502A | 2026-01-08 |
| 00733132663743 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS241502A | VNS241502A | 2026-01-08 |
| 00733132663750 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS241002A | VNS241002A | 2026-01-08 |
| 00733132663767 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS240502A | VNS240502A | 2026-01-08 |
| 00733132663774 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS201502A | VNS201502A | 2026-01-08 |
| 00733132663781 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS201002A | VNS201002A | 2026-01-08 |
| 00733132663798 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS200702A | VNS200702A | 2026-01-08 |
| 00733132663804 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS200502A | VNS200502A | 2026-01-08 |
| 00733132663811 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS181502A | VNS181502A | 2026-01-08 |
| 00733132663828 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS181002A | VNS181002A | 2026-01-08 |
| 00733132663835 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS180702A | VNS180702A | 2026-01-08 |
| 00733132663842 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS180502A | VNS180502A | 2026-01-08 |
| 00733132663859 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS161502A | VNS161502A | 2026-01-08 |
| 00733132663866 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS161002A | VNS161002A | 2026-01-08 |
| 00733132663873 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS160702A | VNS160702A | 2026-01-08 |
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