Flow Re-Direction Endoluminal Device (FRED®) System
FDA premarket approval P180027 · decided 2019-12-16
Approval details
- PMA number
- P180027
- Trade name
- Flow Re-Direction Endoluminal Device (FRED®) System
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- MicroVention, Inc.
- Date received
- 2018-08-01
- Decision date
- 2019-12-16
- Days to decision
- 502 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for The Flow Re-Direction Endoluminal Device (FRED®) System. The Flow Re-Direction Endoluminal Device (FRED®) System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and <= 5.0 mm.
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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 |