Identity
- Trade Name
- iCast Covered Stent System, 5mmX59mmX120cm FDA UDI
- Generic Name
- Peripheral artery endovascular stent-graft, non-medicated FDA UDI
- Device Name
- iCast Covered Stent System, 5mmX59mmX120cm FDA UDI
- Model / Reference
- 42559 FDA UDI
- Description
- iCast Covered Stent System, 5mmX59mmX120cm FDA UDI
Identifiers
- Catalog Number
- 42559 FDA UDI
- Primary DI / UDI-DI
- 00650862425598 FDA UDI
- PMA Number
- P120003 FDA UDI
- FDA Product Code
- PRL FDA UDI
- GMDN Term
- Peripheral artery endovascular stent-graft, non-medicated 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Stent Diameter — 5 Millimeter FDA UDIStent Length — 59 Millimeter FDA UDICatheter Length — 120 Centimeter FDA UDI
Category: Peripheral artery endovascular stent-graft, non-medicated
iCast Covered Stent System, 5mmX59mmX120cm by Atrium Medical Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral artery endovascular stent-graft, non-medicated.
- LifeStream — ClearStream Technologies , Ltd. · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- Fluency® Endovascular Stent Graft — Bard Peripheral Vascular · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- LifeStream — ClearStream Technologies , Ltd. · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
Cleared under the same submission
P120003 also covers:
- iCast Covered Stent System, 10mmX38mmX120cm — Atrium Medical Corp.
- iCast Covered Stent System, 10mmX38mmX80cm — Atrium Medical Corp.
- iCast Covered Stent System, 5mmX16mmX120cm — Atrium Medical Corp.
- iCast Covered Stent System, 5mmX16mmX80cm — Atrium Medical Corp.
- iCast Covered Stent System, 5mmX22mmX120cm — Atrium Medical Corp.
- iCast Covered Stent System, 5mmX22mmX80cm — Atrium Medical Corp.
- iCast Covered Stent System, 5mmX38mmX120cm — Atrium Medical Corp.
- iCast Covered Stent System, 5mmX38mmX80cm — Atrium Medical Corp.
- iCast Covered Stent System, 5mmX59mmX80cm — Atrium Medical Corp.
- iCast Covered Stent System, 6mmX16mmX120cm — Atrium Medical Corp.
- iCast Covered Stent System, 6mmX16mmX80cm — Atrium Medical Corp.
- iCast Covered Stent System, 6mmX22mmX120cm — Atrium Medical Corp.
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
- Atrium Medical Corp.
Sources (1)
- FDA UDI 870bb641-f4cb-45d9-a307-6f2de41680b4 38 fields · synced Jun 8, 2026