Identity
- Trade Name
- GORE VIABAHN VBX Balloon Expandable Endo FDA UDI
- Generic Name
- Peripheral artery endovascular stent-graft, drug-coated FDA UDI
- Device Name
- VIABAHN BX BALLOON EXP ENDO 6mmX79mm 7Fr 135cmCath Heparin FDA UDI
- Model / Reference
- BXA067902A FDA UDI
- Description
- VIABAHN BX BALLOON EXP ENDO 6mmX79mm 7Fr 135cmCath Heparin FDA UDI
Identifiers
- Catalog Number
- BXA067902A FDA UDI
- Primary DI / UDI-DI
- 00733132637492 FDA UDI
- PMA Number
- P160021 FDA UDI
- FDA Product Code
- PRL FDA UDI
- GMDN Term
- Peripheral artery endovascular stent-graft, drug-coated FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 79 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDICatheter Gauge — 7 French FDA UDI
Category: Peripheral artery endovascular stent-graft, drug-coated
GORE VIABAHN VBX Balloon Expandable Endo by W. L. Gore & Associates, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral artery endovascular stent-graft, drug-coated.
- GORE VIABAHN Endoprosthesis with Heparin — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN Endoprosthesis with Heparin — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN Endoprosthesis with Heparin — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN Endoprosthesis with Heparin — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC · Class III
Cleared under the same submission
P160021 also covers:
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
- GORE VIABAHN VBX Balloon Expandable Endo — W. L. GORE & ASSOCIATES, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 81da01ab-df7b-466a-bdee-4b42fd4cda95 37 fields · synced Jun 8, 2026