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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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