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GORE Molding Occlusion Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE Molding Occlusion Balloon Catheter FDA UDI
Generic Name
Intravascular occluding/stent-graft post-dilation balloon catheter FDA UDI
Device Name
MOLDING OCCLUSION BALLOON CATH 10mm - 37mm 10Fr FDA UDI
Model / Reference
MOB37 FDA UDI
Description
MOLDING OCCLUSION BALLOON CATH 10mm - 37mm 10Fr FDA UDI

Identifiers

Catalog Number
MOB37 FDA UDI
Primary DI / UDI-DI
00733132639489 FDA UDI
510(k) Number
K172567 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Intravascular occluding/stent-graft post-dilation balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

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 — 10 French FDA UDI

Category: Intravascular occluding/stent-graft post-dilation balloon catheter

GORE Molding Occlusion Balloon Catheter by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 4f829ae6-9843-4828-84f9-6ee9b866d7ea 37 fields · synced May 30, 2026