Roadsaver/CASPER Carotid Stent Device
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Roadsaver/CASPER Carotid Stent Device FDA PMA
- Generic Name
- Stent, carotid FDA PMA
Identifiers
- PMA Number
- P210030 FDA PMA
- FDA Product Code
- NIM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Roadsaver/CASPER Carotid Stent Device is a carotid stent system intended for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy. It is designed for use in conjunction with the Nanoparasol or EmPro embolic protection system to treat de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries or at the carotid bifurcation.
The device is supplied for use in patients with vessel reference diameters between 3.5 mm and 9.0 mm at the target lesion, requiring ≥50% stenosis if symptomatic or ≥80% stenosis if asymptomatic as defined by angiography. It is a Class III device authorized under FDA PMA P210030 and is intended for use in clinical settings under physician supervision.
Frequently asked questions
What is the Roadsaver/CASPER Carotid Stent Device used for?
The Roadsaver/CASPER Carotid Stent Device is intended for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy, specifically for de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries or at the carotid bifurcation with ≥50% stenosis if symptomatic or ≥80% stenosis if asymptomatic, as defined by angiography.
What vessel sizes are compatible with the Roadsaver/CASPER Carotid Stent Device?
The device is intended for use in vessels with reference diameters between 3.5 mm and 9.0 mm at the target lesion, as specified in the approval criteria for patient eligibility.
What regulatory authorization does the Roadsaver/CASPER Carotid Stent Device have?
The Roadsaver/CASPER Carotid Stent Device is authorized under FDA Premarket Approval (PMA) number P210030, which was granted on November 20, 2024, following receipt of the application on July 28, 2021.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P210030 | Class III | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA PMA P210030 23 fields · synced Sep 18, 2026