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 26mm - 45mm 18Fr FDA UDI
- Model / Reference
- BCL2645 FDA UDI
- Description
- TRI-LOBE BALLOON CATHETER 26mm - 45mm 18Fr FDA UDI
Identifiers
- Catalog Number
- BCL2645 FDA UDI
- Primary DI / UDI-DI
- 00733132605224 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 — 108 Centimeter FDA UDILength — 104 Centimeter FDA UDICatheter Gauge — 18 French 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
K081799 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 73adb5b2-3b2c-49ba-9053-635bb908f175 37 fields · synced Jun 6, 2026