Surpass Evolve Flow Diverter Systems
FDA premarket approval P170024/S015 · decided 2023-12-05
Approval details
- PMA number
- P170024
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Surpass Evolve Flow Diverter Systems
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Stryker Neurovascular
- Date received
- 2023-11-07
- Decision date
- 2023-12-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- approval for the addition of an alternate tier 2 source for raw material polyacrylic acid that is used in the manufacture of the coating of the delivery wire of the Surpass Evolve Flow Diverter System
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
| AXS Lift Intracranial Base Catheter (K253032) | Stryker Neurovascular | 2026-02-11 |
| Target Detachable Coil (K252694) | Stryker Neurovascular | 2025-12-11 |
| InZone IST Detachment System; IZDS Connecting Cable (K251832) | Stryker Neurovascular | 2025-10-17 |
| Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter (K242289) | Stryker Neurovascular | 2025-03-21 |
| AXS Lift Intracranial Base Catheter (K243593) | Stryker Neurovascular | 2025-02-18 |
| Broadway 8 Catheter (K241768) | Stryker Neurovascular | 2024-12-19 |
| Echo Intracranial Base Catheter (K241637) | Stryker Neurovascular | 2024-12-19 |