Lake Region Medical
FDA 510(k) & PMA Approved Devices — 9 products
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Total Devices9
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253746 | Enroute 0.014'' Transcarotid Guidewire | DQX | 2026-03-19 | View |
| 510(k) | K242824 | PTFE Guidewire | DQX | 2024-12-06 | View |
| 510(k) | K221575 | Pre-Formed Blue | DQX | 2022-10-07 | View |
| 510(k) | K211741 | Pre-Formed Extra Support Guidewire | DQX | 2021-11-22 | View |
| 510(k) | K160643 | ENROUTE 0.014 Guidewire | DQX | 2016-10-18 | View |
| 510(k) | K124052 | OSTAVI HYDROPHILIC GUIDEWIRE | OCY | 2013-02-26 | View |
| 510(k) | K112381 | HI TORQUE CONNECT GUIDEWIRE | DQX | 2011-11-03 | View |
| 510(k) | K111288 | ANCHORWIRE GUIDEWIRE | DQX | 2011-08-02 | View |
| 510(k) | K080508 | MANDREL GUIDEWIRES OR M-WIRE | OCY | 2008-03-21 | View |
No matching devices.
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