Synchro SELECT Guidewire
FDA 510(k) clearance K202522 · decided 2020-09-25
Clearance details
- K-number
- K202522
- Device name
- Synchro SELECT Guidewire
- Applicant
- Stryker Neurovascular
- Decision
- Substantially Equivalent
- Date received
- 2020-09-01
- Decision date
- 2020-09-25
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- MOF
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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| Willow 18 Guidewire (K260130) | Arbor Endovascular, LLC | 2026-02-13 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and ar recall (Z-1940-2024) | Stryker Neurovascular | 2024-05-31 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Surpass Streamline Flow Diverter (P170024/S024) | Stryker Neurovascular | 2025-08-20 |
| Neuroform Atlas® Stent System (P180031/S006) | Stryker Neurovascular | 2025-06-24 |
| Surpass Streamline Flow Diverter (P170024/S023) | Stryker Neurovascular | 2025-05-30 |
| Neuroform Atlas Stent System (P180031/S011) | Stryker Neurovascular | 2025-05-09 |
| Surpass Elite Flow Diverter System (P170024/S022) | Stryker Neurovascular | 2025-02-12 |
| Neuroform Atlas Stent System (P180031/S010) | Stryker Neurovascular | 2024-12-09 |
| Neuroform Atlas Stent System (P180031/S009) | Stryker Neurovascular | 2024-11-18 |
| Surpass Elite Flow Diverter System (P170024/S018) | Stryker Neurovascular | 2024-10-16 |