Company ยท US
Lake Region Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 19, 2026 | K253746 | Enroute 0.014'' Transcarotid Guidewire Lake Region Medical, IE | DQX |
| Dec 6, 2024 | K242824 | PTFE Guidewire Lake Region Medical | DQX |
| Oct 7, 2022 | K221575 | Pre-Formed Blue Lake Region Medical | DQX |
| Nov 22, 2021 | K211741 | Pre-Formed Extra Support Guidewire Lake Region Medical | DQX |
| Oct 18, 2016 | K160643 | ENROUTE 0.014 Guidewire Lake Region Medical, IE | DQX |
| Jun 11, 2015 | K151244 | Pre-Formed Guidewire Lake Region Medical | DQX |
| Dec 17, 2014 | K140536 | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE Lake Region Medical, IE | DQX |
| Nov 25, 2014 | K142393 | PREDICATE III GUIDEWIRE Lake Region Medical | DQX |
| Sep 19, 2014 | K142397 | Predicate III Guidewire Lake Region Medical | OCY |
| Apr 8, 2014 | K140482 | MANDREL GUIDEWIRE Lake Region Medical | OCY |
| Apr 7, 2014 | K133155 | HYDROPHILIC COATED GUIDEWIRE Lake Region Medical | DQX |
| Mar 27, 2014 | K140485 | MANDREL GUIDEWIRE Lake Region Medical | DQX |
| Aug 23, 2013 | K130798 | PRE-FORMED GUIDEWIRES Lake Region Medical, Inc. | DQX |
| Feb 26, 2013 | K124052 | OSTAVI HYDROPHILIC GUIDEWIRE Lake Region Medical | OCY |
| Nov 3, 2011 | K112381 | HI TORQUE CONNECT GUIDEWIRE Lake Region Medical, IE | DQX |
| Aug 2, 2011 | K111288 | ANCHORWIRE GUIDEWIRE Lake Region Medical | DQX |
| Mar 21, 2008 | K080508 | MANDREL GUIDEWIRES OR M-WIRE Lake Region Medical | OCY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||