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Lake Region Medical

16 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Enroute 0.014'' Transcarotid Guidewire (K253746)Lake Region Medical2026-03-19
PTFE Guidewire (K242824)Lake Region Medical2024-12-06
Pre-Formed Blue (K221575)Lake Region Medical2022-10-07
Pre-Formed Extra Support Guidewire (K211741)Lake Region Medical2021-11-22
ENROUTE 0.014 Guidewire (K160643)Lake Region Medical2016-10-18
Pre-Formed Guidewire (K151244)Lake Region Medical2015-06-11
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE (K140536)Lake Region Medical2014-12-17
PREDICATE III GUIDEWIRE (K142393)Lake Region Medical2014-11-25
Predicate III Guidewire (K142397)Lake Region Medical2014-09-19
MANDREL GUIDEWIRE (K140482)Lake Region Medical2014-04-08
HYDROPHILIC COATED GUIDEWIRE (K133155)Lake Region Medical2014-04-07
MANDREL GUIDEWIRE (K140485)Lake Region Medical2014-03-27
OSTAVI HYDROPHILIC GUIDEWIRE (K124052)Lake Region Medical2013-02-26
HI TORQUE CONNECT GUIDEWIRE (K112381)Lake Region Medical2011-11-03
ANCHORWIRE GUIDEWIRE (K111288)Lake Region Medical2011-08-02
MANDREL GUIDEWIRES OR M-WIRE (K080508)Lake Region Medical2008-03-21

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Every clearance here is in the API, with alerts when new ones post.