Identity
- Trade Name
- TREO Abdominal Stent-Graft System FDA UDI
- Generic Name
- Aortoiliac endovascular stent-graft FDA UDI
- Device Name
- Endovascular Stent-Graft System FDA UDI
- Model / Reference
- 28-B2-36-080U FDA UDI
- Description
- Endovascular Stent-Graft System FDA UDI
Identifiers
- Catalog Number
- 28-B2-36-080U FDA UDI
- Primary DI / UDI-DI
- 00843576152397 FDA UDI
- PMA Number
- P190015 FDA UDI
- FDA Product Code
- MIH FDA UDI
- GMDN Term
- Aortoiliac endovascular stent-graft 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 36 Millimeter FDA UDIOuter Diameter — 14 Millimeter FDA UDILength — 80 Millimeter FDA UDICatheter Gauge — 19 French FDA UDI
Category: Aortoiliac endovascular stent-graft
TREO Abdominal Stent-Graft System by Bolton Medical Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortoiliac endovascular stent-graft.
- Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
- Endurant® II — MEDTRONIC, INC. · Class III
- Zenith Spiral-Z — COOK INCORPORATED · Class III
- Zenith Renu — COOK INCORPORATED · Class III
- Endurant® II — MEDTRONIC, INC. · Class III
- Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
- Zenith Renu — COOK INCORPORATED · Class III
- Zenith Flex — COOK INCORPORATED · Class III
Cleared under the same submission
P190015 also covers:
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical Inc.
- TREO Abdominal Stent-Graft System — Bolton Medical 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
- Bolton Medical Inc.
Sources (1)
- FDA UDI 4cf81f88-d376-4d3a-8de2-5596c6397402 37 fields · synced May 30, 2026