Surpass Evolve and Elite Flow Diverter
FDA premarket approval P170024/S020 · decided 2024-09-05
Approval details
- PMA number
- P170024
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Surpass Evolve and Elite Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Stryker Neurovascular
- Date received
- 2024-08-07
- Decision date
- 2024-09-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- the addition of an alternate source of raw material (Pharma Grade Sodium Hyaluronate Acid) which is used in the manufacture of the Hydak T-070 top coat solution for the delivery wire
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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 |