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Lake Region Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242824PTFE GuidewireDecember 6, 2024
K221575Pre-Formed BlueOctober 7, 2022
K211741Pre-Formed Extra Support GuidewireNovember 22, 2021
K160643ENROUTE 0.014 GuidewireOctober 18, 2016
K151244Pre-Formed GuidewireJune 11, 2015
K140536HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIREDecember 17, 2014
K142393PREDICATE III GUIDEWIRENovember 25, 2014
K142397Predicate III GuidewireSeptember 19, 2014
K140482MANDREL GUIDEWIREApril 8, 2014
K133155HYDROPHILIC COATED GUIDEWIREApril 7, 2014
K140485MANDREL GUIDEWIREMarch 27, 2014
K130798PRE-FORMED GUIDEWIRESAugust 23, 2013
K124052OSTAVI HYDROPHILIC GUIDEWIREFebruary 26, 2013
K112381HI TORQUE CONNECT GUIDEWIRENovember 3, 2011
K111288ANCHORWIRE GUIDEWIREAugust 2, 2011
K080508MANDREL GUIDEWIRES OR M-WIREMarch 21, 2008