Identity
- Trade Name
- Epic™ Vascular FDA UDI
- Generic Name
- Iliac artery stent, bare-metal FDA UDI
- Device Name
- Self-Expanding Stent System FDA UDI
- Model / Reference
- H74939200104070 FDA UDI
- Description
- Self-Expanding Stent System FDA UDI
Identifiers
- Catalog Number
- H74939200104070 FDA UDI
- Primary DI / UDI-DI
- 08714729805014 FDA UDI
- PMA Number
- P110035 FDA UDI
- FDA Product Code
- NIO FDA UDI
- GMDN Term
- Iliac artery stent, bare-metal 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Iliac artery stent, bare-metal
Epic™ Vascular by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Iliac artery stent, bare-metal.
- Epic™ Vascular — Boston Scientific · Class III
- Epic™ Vascular — Boston Scientific · Class III
- WALLSTENT™ RP Endoprosthesis — Boston Scientific · Class III
- Express® LD Iliac / Biliary — Boston Scientific · Class III
- Epic™ Vascular — Boston Scientific · Class III
- Epic™ Vascular — Boston Scientific · Class III
- Epic™ Vascular — Boston Scientific · Class III
- Express® LD Iliac / Biliary — Boston Scientific · Class III
Cleared under the same submission
P110035 also covers:
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
- Epic™ Vascular — Boston Scientific
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
- Boston Scientific
Sources (1)
- FDA UDI eae0869c-e94c-4b44-a930-72c393f859f4 36 fields · synced May 30, 2026