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GORE® Tri-Lobe Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE® Tri-Lobe Balloon Catheter FDA UDI
Generic Name
Aortic endovascular implant post-dilation balloon catheter FDA UDI
Device Name
TRI-LOBE BALLOON CATHETER 18Fr FDA UDI
Model / Reference
TBCM1634 FDA UDI
Description
TRI-LOBE BALLOON CATHETER 18Fr FDA UDI

Identifiers

Catalog Number
TBCM1634 FDA UDI
Primary DI / UDI-DI
00733132619849 FDA UDI
510(k) Number
K250410 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Aortic endovascular implant post-dilation balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

Dimensions & Sizes

Size
Length — 104 Centimeter FDA UDI
Catheter Gauge — 18 French FDA UDI
Length — 108 Millimeter FDA UDI

Category: Aortic endovascular implant post-dilation balloon catheter

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

Similar devices

Also classified as Aortic endovascular implant post-dilation balloon catheter.

Cleared under the same submission

K250410 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 3406f2d9-775f-4b24-bb83-ac5d725c8410 37 fields · synced May 30, 2026