FDA 510(k) Applications Submitted by Lake Region Medical

FDA 510(k) Number Submission Date Device Name Applicant
K221575 06/01/2022 Pre-Formed Blue Lake Region Medical
K211741 06/07/2021 Pre-Formed Extra Support Guidewire Lake Region Medical
K080508 02/25/2008 MANDREL GUIDEWIRES OR M-WIRE LAKE REGION MEDICAL
K140536 03/04/2014 HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE LAKE REGION MEDICAL
K112381 08/17/2011 HI TORQUE CONNECT GUIDEWIRE LAKE REGION MEDICAL
K140482 02/26/2014 MANDREL GUIDEWIRE LAKE REGION MEDICAL
K140485 02/26/2014 MANDREL GUIDEWIRE LAKE REGION MEDICAL
K111288 05/06/2011 ANCHORWIRE GUIDEWIRE LAKE REGION MEDICAL
K151244 05/11/2015 Pre-Formed Guidewire Lake Region Medical
K142393 08/27/2014 PREDICATE III GUIDEWIRE LAKE REGION MEDICAL
K142397 08/27/2014 Predicate III Guidewire Lake Region Medical
K160643 03/07/2016 ENROUTE 0.014 Guidewire LAKE REGION MEDICAL
K133155 10/17/2013 HYDROPHILIC COATED GUIDEWIRE LAKE REGION MEDICAL
K124052 12/31/2012 OSTAVI HYDROPHILIC GUIDEWIRE LAKE REGION MEDICAL


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