FRED X System
FDA premarket approval P180027/S014 · decided 2025-09-18
Approval details
- PMA number
- P180027
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRED X System
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- MicroVention, Inc.
- Date received
- 2025-06-20
- Decision date
- 2025-09-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval of claims regarding reduced acute material thrombogenicity supported by in-vitro testing on a proprietary device surface modification.
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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 |