Woven EndoBridge (WEB) Aneurysm Embolization System
FDA premarket approval P170032 · decided 2018-12-31
Approval details
- PMA number
- P170032
- Trade name
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Generic name
- Intrasaccular Flow Disruption Device
- Applicant
- MicroVention, Inc.
- Date received
- 2017-09-28
- Decision date
- 2018-12-31
- Days to decision
- 459 days
- Decision code
- APPR
- Product code
- OPR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for use in adults to embolize saccular intracranial wide neck bifurcation aneurysms located in the anterior (middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex) and posterior (basilar apex) circulations, ranging in size from 3 mm to 10 mm in dome diameter, where the neck size is 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.
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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 |