Roadsaver/CASPER Carotid Stent Device
FDA premarket approval P210030 · decided 2024-11-20
Approval details
- PMA number
- P210030
- Trade name
- Roadsaver/CASPER Carotid Stent Device
- Generic name
- Stent, carotid
- Applicant
- MicroVention, Inc.
- Date received
- 2021-07-28
- Decision date
- 2024-11-20
- Days to decision
- 1211 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tistin, CA
- Statement
- Approval for the Roadsaver (or CASPER) Carotid Stent System, when used in conjunction with the Nanoparasol (or EmPro) embolic protection system, is intended for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy and meet the criteria outlined below:1. Patients who have either de novo atherosclerotic or post endarterectomy restenotic lesion(s) in the internal carotid arteries or at the carotid bifurcation with ?50% stenosis
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Wedge XL Delivery Catheter (K232542) | MicroVention, Inc. | 2024-05-16 |
| SOFIA EX Intracranial Support Catheter (K230775) | MicroVention, Inc. | 2023-09-14 |
| EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (K222694) | MicroVention, Inc. | 2023-04-27 |
| ISAAC Neurovascular Navigation Catheter (K222115) | MicroVention, Inc. | 2023-01-10 |
| AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) (K223050) | MicroVention, Inc. | 2022-12-21 |
| SOFIA 88 Catheter (K214024) | MicroVention, Inc. | 2022-09-12 |
| ERIC Retrieval Device (K211120) | MicroVention, Inc. | 2022-03-31 |
| BOBBY Balloon Guide Catheter (K193607) | MicroVention, Inc. | 2020-07-21 |