Identity
- Trade Name
- LVIS FDA UDI
- Generic Name
- Bare-metal intracranial vascular stent FDA UDI
- Device Name
- Stent FDA UDI
- Model / Reference
- 212517-LVIS-C FDA UDI
- Description
- Stent FDA UDI
Identifiers
- Catalog Number
- 212517-LVIS FDA UDI
- Primary DI / UDI-DI
- 00810170018619 FDA UDI
- PMA Number
- H130005 FDA UDI
- FDA Product Code
- NJE FDA UDI
- GMDN Term
- Bare-metal intracranial vascular stent FDA UDI
Classification
- Device Class
- Unclassified 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
Category: Bare-metal intracranial vascular stent
Lvis by Microvention Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Surpass Elite — Stryker Corp. · Class III
- Pipeline — Micro Therapeutics, Inc. · Class III
- Surpass Elite — Stryker Corp. · Class III
Cleared under the same submission
H130005 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 Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Microvention Inc.
Sources (1)
- FDA UDI 38c77b6c-53bd-4ac2-b4ec-f70e9e7a64b9 37 fields · synced May 30, 2026