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GORE VIABAHN VBX Balloon Expandable Endo

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

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 8mmX39mm 7Fr 80cmCath Heparin FDA UDI
Model / Reference
BXAL083901A FDA UDI
Description
VIABAHN BX BALLOON EXP ENDO 8mmX39mm 7Fr 80cmCath Heparin FDA UDI

Identifiers

Catalog Number
BXAL083901A FDA UDI
Primary DI / UDI-DI
00733132637812 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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 7 French FDA UDI
Outer Diameter — 8 Millimeter FDA UDI
Length — 39 Millimeter 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.

Cleared under the same submission

P160021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 0da1e313-e96f-4fa4-a1d0-df6a403f4670 37 fields · synced Jun 8, 2026